DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

Advisory Committee on 

Immunization Practices (ACIP)

Summary Report

December 19-20, 2020 

Atlanta, Georgia 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Table of Contents Page

Agenda 3 

Acronyms 4-6 

December 19, 2020

Welcome and Introductions 8-10

Coronavirus Disease 2019 (COVID-19) Vaccines

 Introduction

 mRNA-1273 Development Program

 GRADE: Moderna COVID-19 Vaccine

 Evidence to Recommendation Framework: Moderna COVID-19 Vaccine

 Update on COVID-19 Vaccines and Anaphylaxis

 Clinical Considerations for Use of mRNA COVID-19 Vaccines

 Vote: Moderna COVID-19 Vaccine

10-40

December 20, 2020

Welcome and Introductions 40-42

Coronavirus Disease 2019 (COVID-19) Vaccines

 Introduction

 Allocation of initial supplies of COVID-19 vaccine: Phase 1b and 1c

42-72

Certification 73

Membership Roster 74-83
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Acronyms

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

ACS American Community Survey 

AE Adverse Event

AECI Adverse Events of Clinical Interest 

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ARDS Acute Respiratory Distress Syndrome 

ASTHO Association of State and Territorial Health Officers 

BMI Body Mass Index

BRFSS Behavioral Risk Factor Surveillance System 

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CISA Cybersecurity and Infrastructure Security Agency

CKD Chronic Kidney Disease

CLD Chronic Liver Disease 

CLL Chronic Lymphocytic Leukemia 

CMS Center for Medicare and Medicaid Services

COI Conflict of Interest 

COP Cryptogenic Organizing Pneumonia 

COPD Chronic Obstructive Pulmonary Disease 

COU Clinical Operations Unit 

COVID-19 Coronavirus Disease 2019 

CoVPN COVID-19 Prevention Network 

CSTE Council of State and Territorial Epidemiologists 

DART Developmental and Reproductive Toxicology Study 

DBP Diastolic Blood Pressure 

DNA Deoxyribonucleic Acid 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DSPC 1,2-distearoyl-sn-glycero-3-phosphocholine 

DSTDP Division of STD Prevention 

DVA Department of Veterans Affairs
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DVD Division of Viral Diseases 

ED Emergency Department

EHR Electronic Health Record 

EIS Epidemic Intelligence Service

ELISA Enzyme-Linked Immunosorbent Assay 

EMA European Medicines Agency 

EMR Electronic Medical Record 

EtR Evidence to Recommendation 

EU European Union 

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FQHC Federally Qualified Health Center 

FRN Federal Register Notice 

FY Fiscal Year 

GBS Guillain-Barré Syndrome 

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCP Health Care Personnel / Providers

HCW Health Care Workers 

HHS (Department of) Health and Human Services

HIV Human Immunodeficiency Virus 

HR Heart Rate

HRSA Health Resources and Services Administration 

IDCRC Infectious Disease Clinical Research Consortium 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IIS Immunization Information Systems 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

LTCF Long-Term Care Facilities 

MAAE Medically-Attended Adverse Event

MedDRA Medical Dictionary for Regulatory Activities 

mITT Modified Intention to Treat 

MMWR Morbidity and Mortality Weekly Report

mRNA Messenger Ribonucleic Acid 

MIS-C Multisystem Inflammatory Syndrome in Children 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NAS National Academy of Sciences 

NASEM or the 

National 

Academies

National Academies of Sciences, Engineering, and Medicine 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NFID National Foundation for Infectious Diseases 
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NHANES National Health and Nutrition Examination Survey 

NHIS National Health Interview Survey 

NHP Non-Human Primates 

NHSN National Healthcare Safety Network 

NIAID National Institute of Allergy and Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

NPI Non-Pharmaceutical Intervention

NVPO National Vaccine Program Office 

NVSN New Vaccine Surveillance Network 

NYC New York City

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

OWS Operation Warp Speed 

PaO2/FIO2 Arterial Oxygen Partial Pressure

PBS Phosphate-Buffered Saline 

PCR Polymerase Chain Reaction 

PEG Polyethylene Glycol 

PEP Post-Exposure Prophylaxis

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

PMR Polymyalgia Rheumatica 

POD Point-of-Dispensing 

PPE Personal Protective Equipment 

PT Preferred Terms (MedDRA)

QI Quality Improvement

RCT Randomized Controlled Trial

RR Respiratory Rate

RR Relative Risk

rRT-PCR Real-Time Reverse Transcription Polymerase Chain Reaction 

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAB Spontaneous Abortion

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2 

SBP Systolic Blood Pressure 

SHEA Society for Healthcare Epidemiology of America 

SJS Stevens-Johnson Syndrome 

SLU Saint Louis University 

SpO2 Oxygen Saturation

SVI Social Vulnerability Index 

UK United Kingdom

US United States

USG US Government 

USPHS US Public Health Service 
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VA (US Department of) Veteran’s Affairs 

VAERD Vaccine-Associated Enhanced Respiratory Disease 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Subgroup 

VE Vaccine Efficacy

VE Vaccine Effectiveness

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

VSD Vaccine Safety Datalink

VTU Vaccine Treatment Evaluation Unit 

WG Work Group
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Call To Order, Welcome, Overview, Announcements, & Roll Call/Introductions

José Romero, MD, FAAP

ACIP Chair

Amanda Cohn, MD

Executive Secretary, ACIP / CDC

Dr. Romero called to order the December 19-20, 2020 emergency meeting of the Advisory 

Committee on Immunization Practices (ACIP), the purpose of which was to discuss and vote on 

the Moderna Coronavirus Disease 2019 (COVID)-19 vaccine. 

Dr. Cohn welcomed everyone and noted that the final agenda and webcast link could be 

accessed on the ACIP website, and that copies of the slides for this meeting could be accessed 

at the following URL: 

https://www.cdc.gov/vaccines/acip/meetings/slides-2020-12-19-20.html 

Additionally, the slides to be presented during this meeting were made available through a 

ShareFile link for ACIP Voting, Liaison, and Ex-Officio members. The live webcast videos will be 

posted approximately 1 week following the meeting, and the meeting minutes also will be

posted to the ACIP website.

In terms of meeting logistics, participants were instructed to raise their hands virtually when Dr. 

Romero opened the floor for discussion and to disable their video or mute their phone lines to 

reduce issues with the Zoom connection. Dr. Cohn explained that during the discussion period, 

the order in which Dr. Romero would take questions would be first from ACIP Voting Members, 

second from Ex Officio and Liaison member representatives, and then from the audience. The 

plan was to stay on schedule with the meeting agenda as much as possible. 

The next regularly scheduled ACIP meeting will be convened on February 24-25, 2021. An 

emergency meeting will be scheduled and announced if data become available that ACIP needs 

to consider before that time. 

Dr. Cohn explained that there would be an oral public comment session prior to each vote. 

Given that many more individuals registered to make oral public comments than could be 

accommodated, selection was made randomly via a lottery. Those individuals who were not 

selected and any other individuals wishing to make written public comments may submit them 

through https://www.regulations.gov using Docket Number CDC-2020-0124. Further information 

on the written public comment process can be found on the ACIP website.

ACIP members agree to forgo participation in certain activities related to vaccines during their 

tenure on the committee. For certain other interests that potentially enhance a member’s 

expertise, CDC has issued limited conflict of interest (COI) waivers. Members who conduct 

vaccine clinical trials or serve on data safety monitoring boards (DSMBs) may present to the 

committee on matters related to those vaccines, but are prohibited from participating in 

December 19, 2020: Opening Session 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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committee votes. Regarding other vaccines of the concerned company, a member may 

participate in discussions with the provision that he/she abstains on all votes related to that 

company. At the beginning of each meeting, ACIP members state any COIs. The first vote is a 

vaccine product-specific vote for which 3 ACIP members will abstain due to COIs or perceived 

COIs. The second vote is a general vote on prioritization for which no members will need to 

abstain.

Dr. Romero conducted a roll call of ACIP members, during which the following COIs were 

declared:

 Dr. Robert Atmar is serving as the Co-Director of the Clinical Operations Unit (COU) of the 

National Institutes of Health (NIH)-funded Infectious Diseases Clinical Research Consortium

(IDCRC) that is working within the COVID-19 Prevention Network (CoVPN) to evaluate 

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) vaccine candidates in 

Phase 3 clinical trials. She is the Site Principal Investigator (PI), including those produced by 

Moderna, AstraZeneca, Janssen, Novavax, and Sanofi. 

 Dr. Sharon Frey is employed by Saint Louis University (SLU), which has a Vaccine 

Treatment Evaluation Unit (VTU) that is part of the IDCRC. She is currently serving as the 

Site PI for the Moderna and Janssen Phase III COVID-19 vaccine clinical trials. 

 Dr. Paul Hunter owns a small amount of stock in Pfizer and has received a small grant from 

Pfizer to conduct a quality improvement (QI) project on pneumococcal vaccines.

A list of Members, Ex Officio Members, and Liaison Representatives is included in the 

appendixes at the end of the full minutes for the December 19-20, 2020 ACIP meeting.

Food and Drug Administration (FDA) Update

Doran Fink, MD, PhD

Deputy Director-Clinical

Division of Vaccines and Related Products Applications

Center for Biologics Evaluation and Research 

Food and Drug Administration

Dr. Fink provided an overview of the Vaccines and Related Biological Products Advisory 

Committee (VRBPAC) meeting on December 17, 2020 and the Emergency Use Authorization 

(EUA) issued on December 18, 2020 for the Moderna COVID-19 vaccine. Like the Pfizer 

COVID-19 vaccine for which an EUA was issued the previous week, the Moderna product is an 

messenger ribonucleic acid (mRNA) and lipid particle vaccine. The Moderna vaccine is 

authorized for emergency use for active immunization for prevention of COVID-19 caused by 

the SARS-CoV-2 virus in individuals 18 years of age and older. This EUA followed a 

comprehensive FDA review of data submitted in support of the request, as well as a meeting of 

the VRBPAC. The outcome of the VRBPAC meeting was a nearly unanimous vote in favor of 

the benefits of the vaccine outweighing its risks for EUA, with 20 members voting in favor and 1 

member abstaining. FDA continues to work very closely with its partners at CDC and the United 

Kingdom (UK) to investigate reports of suspected allergic reactions following use of the Pfizer 

vaccine in ongoing vaccination campaigns. Some of these reactions have been confirmed to be 

serious or anaphylactic reactions. FDA is working closely with the manufacturer to identify what 

the cause of these reactions might be. FDA will update the public in a timely manner if anything 

is found that would cause them to change the conditions of the EUA or if any additional 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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information needs to be provided to the public about the benefits and risks of the vaccine. Dr. 

Fink stressed that at this time, the totality of the data continues to support vaccination under the 

Pfizer EUA without any new restrictions. FDA thanks the public for remaining vigilant and 

reporting reactions to the vaccine using the established mechanisms.

Introduction

Beth Bell, MD, MPH 

ACIP, COVID-19 Vaccine WG Chair

Clinical Professor, Department of Global Health

School of Public Health, University of Washington 

Dr. Bell introduced the session indicating that the agenda for the December 19-20, 2020 

meeting would include presentations on the following topics:

December 19, 2020

 mRNA-1273 Development Program

 Grading of Recommendation Assessment, Development and Evaluation (GRADE): Moderna 

COVID-19 Vaccine

 Evidence to Recommendation Framework (EtR): Moderna COVID-19 Vaccine

 Update on COVID-19 Vaccines and Anaphylaxis

 Clinical Considerations for use of mRNA COVID-19 vaccines

 Public Comment Prior to the Vote

 Vote on the Moderna COVID-19 Vaccine

December 20, 2020

 Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b and 1c

 Public Comment Prior to the Vote

 Vote on Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b and 1c

Overview of Moderna’s COVID-19 Vaccine mRNA-1273

Jacqueline M. Miller, MD, FAAP

Senior Vice President

Infectious Disease Development

Moderna, Inc.

Dr. Miller said that on behalf of Moderna, it gave her great pleasure to present an overview of 

the Moderna COVID-19 vaccine and clinical development program. In terms of the mRNA 

platform, the Moderna vaccine is a single sequence of mRNA that encodes for the spike protein 

of SARS-CoV-2. The mRNA is synthesized from a deoxyribonucleic acid (DNA) template. The 

nucleotides present in mRNA are then enzymatically buffered with FDA-approved buffers. The 

mRNA is then protected from degradation by the body’s natural lytic enzymes with a lipid 

nanoparticle (LNP). The LNP serves to both protect the mRNA and also target it via the 

lymphatic of the draining lymph nodes for antigen-presenting cells. Both dendritic cells and 

subcapsular macrophages take up the mRNA for further processing and expression. The final 

Coronavirus Disease 2019 (COVID-19) Vaccines: Moderna mRNA Vaccine
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drug product is a lipid product that will be presented in a 10-dose vial. The LNP targets the 

mRNA for delivery to the draining lymph nodes and once at the antigen-presenting cell, the 

mRNA is released into the cell cytosol where it is taken up by the ribosomes whose job it is to 

translate mRNA into protein. The spike protein amino acid is then synthesized and naturally 

assembles into its trimeric form and is expressed on the cell surface as through normal viral 

infection.

To give a brief overview of the pre-clinical and early clinical data, Moderna conducted a robust 

non-clinical program in 3 different animal models in order to demonstrate that the vaccine was 

immunogenic and that there were no safety concerns before taking it into human clinical 

development. The vaccine drives a robust SARS-CoV-2 specific antibody and Th1-directed 

CD4+ and CD8+ T-cell response in mice, Golden Syrian hamsters, and non-human primates 

(NHP). The NHPs and mice also were challenged with SARS-CoV-2 after vaccination. Even in 

those with lower doses than those administered to humans, challenge did not lead to vaccineassociated enhanced respiratory disease (VAERD). In addition, Moderna recently completed its 

Developmental and Reproductive Toxicology Study (DART) and has submitted it to the FDA. No 

safety concerns were identified.

Overall, Moderna has conducted a full development program, including a Phase 1, Phase 2, 

and Phase 3 study. The starts of those studies was staggered in order to enable the acquisition 

of safety data from one phase before moving on to initiate clinical trials in the next phase. A 

Phase 1 dose ranging study, Phase 2 safety and immunogenicity study, and Phase 3 safety and 

efficacy study have been conducted. In terms of the early phase studies, neutralizing antibody 

titers were observed in all participants following the second dose. The geometric mean titers 

(GMTs) across age strata are numerically higher than in a pool of convalescent sera. 

Neutralizing antibodies have persisted for at least 3 months after the second dose and still 

remain numerically higher than the panel of convalescent sera. A strong Th1 dominant, CD4+ 

T-cell response also has been observed. The results from the early phase studies were 

consistent with results from pre-clinical findings.

In Study 301, the Phase 3 safety and efficacy trial, 30,420 subjects were randomized 1:1 to 

receive either 2 doses of 100 μg of mRNA-1273 or a saline placebo. Over 15,000 subjects were 

randomized to each arm and participants received 2 doses separated by 29 days. Active COVID 

surveillance was performed throughout the course of the study. Doses were given at Day 1 and 

Day 29. Subjects received daily phone calls to solicit safety information each week for one 

month after vaccination. They reported their solicited symptoms on an eDiary card and serious 

adverse events (SAEs) and medically-attended adverse events (MAAEs) have been solicited 

throughout the study. Once subjects exited the vaccination phase, they continued to provide 

data through weekly eDiary prompts for COVID-19 symptoms and monthly safety calls to make 

sure safety information was captured. For primary disease, subjects had to have 2 systemic 

symptoms including fever, chills, myalgia, headache, sore throat, new olfactory and taste 

disorder(s) or at least 1 respiratory symptom, including cough, shortness of breath / difficulty 

breathing, clinical or radiographical evidence of pneumonia and a positive nasopharyngeal swab 

for SARS-CoV-2 virus. These cases have been adjudicated by an endpoint adjudication 

committee and they had to occur 2 weeks after the second dose.
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To be considered in the secondary efficacy endpoint against severe COVID-19 disease, 

participants had to meet all of the characteristics of the primary case definition and at least one 

of the 4 following conditional criteria:

 Clinical signs indicative of severe systemic illness, respiratory rate (RR) ≥ 30 per minute,

heart rate (HR) ≥ 125 BPM, oxygen saturation (SpO2) ≤ 93% on room air at sea level or 

arterial oxygen partial pressure (PaO2/FIO2) < 300 mm Hg

 Respiratory failure or acute respiratory distress syndrome (ARDS), evidence of shock:

systolic blood pressure (SBP) < 90 mm Hg, diastolic blood pressure (DBP) < 60 mm Hg or 

requiring vasopressors

 Significant acute renal, hepatic or neurologic dysfunction

 Admission to ICU or death

It was very important to Moderna from the start to include subjects at highest risk for severe 

complications of COVID-19, so they stratified enrollment to include at least 25% and up to 50% 

of participants who were either ≥ 65 years of age or between 18 to < 65 with at least one 

medical condition putting them at increased risk for severe COVID-19. Across the study, 42% of 

subjects were enrolled who fell into the high risk category. Moderna also wanted to enroll an 

inclusive clinical trial knowing that communities of color have been disproportionately impacted 

by COVID-19. Of the subjects enrolled, approximately 10% are African American, 5% are Asian 

American, and 20% are self-identified as Hispanic.

In terms of the comorbid conditions, between the 18 to < 65 and ≥ 65 years of age groups, 23% 

reported at least 1 pre-existing medical condition. Of the conditions specifically captured, 9% 

had diabetes, 7% had severe obesity defined by body mass index (BMI) of >40 kg/m2

, 5% had 

chronic lung disease, 5% had significant cardiac disease, less than 1% had liver disease, and 

less than 1% had human immunodeficiency virus (HIV). Individuals also were specifically sought 

out who were at increased risk of acquiring COVID-19 due to their occupation or living 

circumstances. Of the participants enrolled in the trial, 25% were healthcare workers and the 

essential workers that are part of Phase 1b of CDC’s plan comprised an additional 25% of the 

trial.

The primary efficacy analysis defined per protocol had included at least 151 cases. Overall, the 

primary efficacy analysis was performed on 196 cases that met the case definition for the 

primary endpoint. There were 11 cases in the mRNA-1273 group and 185 cases in the placebo 

group for an overall vaccine efficacy of 94.1%. The lower limit of the 95% confidence interval 

was 89.3%, which exceeded the pre-specified statistical criterion of 30%. The p-value was 

highly significant at < 0.0001 and the impact of this efficacy can be seen in the difference in 

incidence rates, which were 3.3/1000 person years in the vaccine group as compared to 

56.5/1000 person years in the placebo group. Various subgroup analyses also were performed 

on demographic characteristics to evaluate the consistency of this efficacy estimate. Across age 

demographics as well as gender and race, efficacy was consistent with the primary efficacy 

endpoint.

Vaccine efficacy against severe disease was analyzed as a secondary endpoint. There were 30 

cases reported at the time of the analysis, all of which had occurred in the placebo group for an 

efficacy estimate of 100%. The occurrence of symptomatic COVID-19 disease after the first 

dose also was analyzed as a secondary endpoint. The point estimate of efficacy for cases which 

occurred 14 days after Dose 1 was 95.1%. This indicates a convergence of a cumulative 

distribution curve at approximately 10 days after the first dose.
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Some additional analyses were performed to further evaluate the accumulation of cases after 

the first dose. In terms of the modified intention-to-treat (mITT) population and the accumulation 

of cases based on the CDC case definition, which is less restrictive than the primary endpoint 

and requires a single reported symptom on an expanded list of symptoms, there were overall 62 

cases in the placebo group as compared to 8 cases in the mRNA-1273 group. The majority of 

cases were reported in the first 2 weeks after administration of Dose 1 I the 1273 group. These 

data suggest that protection may begin prior to Dose 2, although both doses should be given for 

full protection.

There also is a pre-specified secondary efficacy endpoint for asymptomatic disease. That 

efficacy endpoint relies on seroconversion to anti-nucleic acid antibody. At the time of 

Moderna’s EUA submission, the serology data were not yet available for evaluation. Prevaccination nasal swabs against the SARS-CoV-2 virus were obtained and therefore, Moderna 

summarized the percentage of subjects who had positive nasal swabs prior to administration of 

Dose 1 and Dose 2. These data were used to look further into the question of asymptomatic 

infection. There were 38 positive swabs in the placebo group as compared to 14 positive swabs 

in the mRNA-1273 group, representing nearly a two-thirds reduction in positive swabs. Again, 

this suggests that there may be efficacy against asymptomatic infections. Further data will 

follow.

Transitioning to the safety analysis performed after a median duration of 9 weeks of safety 

follow-up, subjects were specifically queried about solicited adverse reactions on an electronic 

diary card. This information was captured in all 30,000 subjects enrolled. The reactions captured 

included injection site pain, erythema, swelling, and swelling or tenderness in the draining lymph 

nodes adjacent to the vaccinated arm. Overall, the most commonly reported symptom was 

injection site pain. This was more frequently reported in subjects 18 to 65 years of age as 

compared to those over 65 years of age. There was more frequent reporting in the mRNA-1273 

group of injection site reactions after Dose 2 as compared to after Dose 1. The majority of 

symptoms were still mild to moderate in severity and had a median duration of 2 to 3 days.

After Dose 1 for the mRNA-1273 and placebo groups stratified by age, the older adults tended 

to report systemic adverse reactions less frequently than younger adults. Interestingly in the 

placebo group, close to 30% of subjects reported fatigue and headache in the group 18 to 55 

years of age. Again, the majority of symptoms were mild to moderate in severity. There was an 

increase in the reported rates and severity of local solicited symptoms after the second dose. 

Again, there was more frequent reporting in the younger versus the older age cohorts. Over 

96% of subjects were compliant with the 2-dose vaccination schedule. As with the local solicited 

symptoms, the general solicited symptoms had a median duration of 3 days or less.

In terms of solicited local reactions by patients who were found to be baseline positive for 

SARS-CoV-2, the subjects were excluded if they reported a known history of COVID-19 

disease. Baseline screening was performed for serology against anti-nucleocapsid antibody 

indicating past infection and nasopharyngeal swabs for SARS-CoV-2 infection to indicate 

current infection. Those subjects were enrolled into the trial. Moderna wondered whether 

subjects would report an increased rate of adverse reaction if they had previously been exposed 

to the spike protein, which was not observed to the be the case.

Unsolicited adverse events were captured by subjects through a memory aid and interviews by 

site staff through the weekly phone calls at a month after vaccination and then monthly 

thereafter. Overall, the rates of AEs were comparable between the treatment groups, including 

MAAEs and SAEs. The excess of infections and infestations in the placebo group was primarily 
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due to COVID-19. The patterns were very similar for the rates of SAEs that were reported 

throughout the study. Again, rates were comparable between the two groups. Deaths were 

reported throughout the study. The only cause of death (COD) that was reported in more than 

one subject per group was myocardial infarction. The review of the CODs did not lead to any 

safety concerns. All of the deaths have been assessed as not related by the investigators.

Because of the recent discussion of anaphylaxis following vaccination with another mRNA 

vaccine, Dr. Miller described the cases observed in Study 301. Importantly, participants were 

not excluded if they had a general history of anaphylaxis, urticaria, or other significant 

hypersensitivity. Subjects were excluded if they had a known allergy or anaphylactic reaction to 

a component of the vaccine. At the time of the EUA submission, 2 anaphylactic reactions had 

been reported as unsolicited AEs. The first was in the placebo and occurred 10 days after the 

first dose in a subject who received radiocontrast dye, while the second was in the mRNA-1273 

group and occurred 63 days after the second dose in a subject who reported a history of allergy 

to shellfish. There was another anaphylaxis the previous day in the placebo group, which is still 

under investigation. They also wanted to look at the reactions that could be classified as 

anaphylaxis within the 48 hours after vaccination. This was done through a Standardized 

MedDRA Query (SMQ). In the mRNA-1273 group, 4 cases were identified. None of them met 

the Brighton Collaboration definition for anaphylaxis. All of them were Grade 1 or 2 in severity, 

none of them was serious, and all recovered.

In terms of the safety surveillance that will continue as Moderna transitions to the continuation of 

the Phase 3 study and for individuals who will be vaccinated with mRNA-1273 moving forward, 

they recognize that vaccination of pediatric patients will be important. Moderna has an ongoing 

study in adolescents 12 to 18 years of age, which began earlier in December. Moderna is in 

discussion with the National Institutes of Health (NIH) and the IDCRD for a study design for a 

pediatric clinical trial in younger children ranging from 6 months of age to 12 years of age. 

Moderna will soon initiate a collaboration with the National Cancer Institute (NCI) to evaluate the 

safety and immunogenicity of the vaccine in patients with cancer. Moderna will also be actively 

participating in the post-authorization surveillance that will be conducted by the FDA and CDC. 

In addition, Moderna will be launching its own post-authorization safety study in a large 

insurance database to investigate reported AEs after vaccination. They are developing a global 

pregnancy registry. Now that the DART study results are available and there is a positive 

efficacy and a reassuring safety signal in non-pregnant adults, Moderna is ready to consider 

conducting clinical trials in pregnant women. Finally, Moderna will be conducting a postauthorization effectiveness study with Kaiser Southern California to look at the effectiveness of 

mRNA-1273 in the real-world use setting. Moderna also will continue to collaborate with NIH, 

FDA, CDC, and other government agencies in order to further investigate the efficacy and 

safety of the vaccine.

With regard to vaccine storage and handling, the mRNA-1273 vaccine is shipped at -20°C (-

40°C to -15°C). The minimal shipment order is 100 doses and the vaccine is packaged in a 10-

dose vial, with 10 vials to a carton. The vaccine can be stored at 2°C to 8°C in the refrigerator 

for 30 days. Once thawed for use, it can be held at room temperature for up to 12 hours. Once 

the multiple dose vial has been punctured, it needs to be used within 6 hours because the 

vaccine contains no preservatives. It is a liquid formulation, so no further dilution is required.

In summary, mRNA-1273 demonstrated 94.1% efficacy in the primary analysis based on 196 

cases. The primary efficacy hypothesis was met with a lower limit of the 95% CI of 89.3%, 

exceeding pre-specified 30% margin. The vaccine was observed to reduce the incidence of 

severe COVID-19 disease, with 30 cases observed in the placebo group at the time of the 
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analyses. Other secondary, sensitivity, and subgroup analyses support the primary efficacy 

analysis results. An acceptable tolerability profile has been observed with >96% of subjects 

having received a second dose. More solicited AEs were reported after the second dose, but 

the majority of reported solicited AEs were mild-to-moderate in severity and short-lived in 

duration. The safety profile is overall clinically acceptable and therefore, mRNA-1273 has the 

potential to address the SARS-CoV-2 pandemic and has been authorized for emergency use.

Discussion Points

Referring to slide 30, Dr. Ault requested additional information about whether there were any 

Grade 4 reactions.

Dr. Miller indicated that there were a few Grade 4 reactions, but they occurred at a low 

percentage making it difficult to see on the slide. The Grade 4 reactions were only on the 

solicited general symptoms and were in the areas of fever, arthralgia, myalgia, and headache. 

Dr. Frey inquired as to whether there were any autoimmune cases, unusual pneumonias, or 

other presentations discussed by safety monitors or safety committees in relation to a possible 

hyper-response or something that would be suggestive of a Th2-biased response in the first 28 

days after vaccination. In addition, she wondered whether there were any unusual rashes or 

other skin conditions seen post-vaccination.

Dr. Miller indicated that the investigators looked at how many patients reported autoimmune 

conditions by medical history when entering the trial. There were approximately 1200 subjects in 

each group. Autoimmune conditions overall were assessed and no imbalances were seen 

between the groups. For example, there was one case of rheumatoid arthritis that occurred in 

the mRNA-1273 group and one case of polymyalgia rheumatica (PMR) occurred in the placebo 

group. One SAE was assessed by the investigator as potentially vaccine-related regarding a 

cryptogenic organizing pneumonia (COP). However, that subject had a number of samples for 

SARS-CoV-2 and none were ever identified as positive because of the COP. Therefore, the 

cause of the COP remains unknown. As with the local injection site reactions, there was an 

excess of cases of injection site rash and urticaria reported in the mRNA-1273 group. A small

subset of subjects reported some delayed injection site reaction beyond the 8-day reporting 

period. Approximately 90 of these occurred after Dose 1 and fewer after Dose 2. Only 2 

subjects had reactions after both Dose 1 and Dose 2. This topic was discussed by the DSMB 

and also was referred to a dermatopathology as these rashes tended to be erythematous with 

essential rigidity. The assessment of these rashes was that they were likely to be due to a 

localized immune reaction in the dermis and not a systemic reaction such as Stevens-Johnson 

Syndrome (SJS). The subjects were well during the events, were able to engage in normal 

activities, and the events have resolved.

Dr. Poehling asked how many people who were enrolled became pregnant during the trial and 

what the outcomes of those pregnancies have been to date. In addition, she inquired as to the 

experience with Bell’s Palsy and when it occurred after vaccine or placebo.

Dr. Miller indicated that 13 pregnancies have been reported throughout the trial. Because the 

results of the DART study were not yet in, pregnancy tests were done upon enrollment and prior 

to each vaccination. Women were asked to continue to use contraception and refrain from 

becoming pregnant until 3 months after their second vaccination. Of those 13 pregnancies, 7 

have occurred in the placebo group and 6 have occurred in the mRNA-1273 group. There are 

outcomes for 3 of the pregnancies. One of the placebo subjects has been lost to follow-up, 1 of 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

16

the placebo subjects underwent spontaneous abortion, and a third placebo subject underwent 

elective termination. The remaining pregnancies continue and will be followed for full outcome. 

There have been 4 cases of Bell’s Palsy reported in the clinical trial thus far. Of these, 3 

occurred in the mRNA-1273 group and 1 occurred in the placebo group. All cases occurred 

between 16 and 32 days after vaccination. The cases are all resolved or resolving at this point.

Dr. Romero asked what the constituents are of the excipients and of the LNP of the Moderna 

vaccine and if there are any similarities between the Moderna and Pfizer vaccines.

Dr. Moore indicated that the excipients in the Moderna product are sucrose and 2 

pharmaceutical buffers, tris and acetate. Moderna’s buffer system is different from Pfizer’s in 

that Pfizer uses phosphate-buffered saline (PBS). Moderna’s LNPs contain 4 constituents. One 

is an RNA-binding lipid that is a proprietary lipid developed by Moderna that breaks down 

rapidly in the body; one is 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), which is a 

natural component of human lung surfactant; one is cholesterol; and one is polyethylene glycol 

(PEG) lipid to keep the LNPs from fusing in the vial. That is all that is in the vaccine in addition 

to the RNA. The difference in Moderna’s product from Pfizer’s is that Moderna uses different 

proprietary RNA-binding lipids.

Dr. Bernstein asked what mitigation recommendations were made to study participants such as 

wearing masks. He also noted that race and ethnicity on slide 21 looked encouraging in terms of 

communities of color benefiting from the vaccine. He was surprised that there were twice as 

many cases in the non-Hispanic whites than in the communities of color given that the 

epidemiology suggests that communities of color are more likely to get COVID-19. Relating to 

the potential allergic manifestations, Dr. Bernstein noticed in the Phase I trial there were 3 

withdrawals for hives, a maculopapular rash, and a sore throat and Dr. Miller mentioned dermal 

hypersensitivity at the injection site that also included pruritus. He also noticed that under the

SAEs reported by at least 2 subjects there was swelling of the face. 

Dr. Miller indicated that the study investigators had a discussion during the investigator meeting 

pertaining to measures such as mask wearing. The reason people at highest risk for disease 

were enrolled was because they know that they need to be able to capture cases in order to 

assess vaccine efficacy. The subjects in the trial were at increased risk based on their 

geography, occupation, medical comorbidities, or age. They were encouraged to keep 

themselves safe. Regarding slide 21 and race and ethnicity, the study was designed to assess 

COVID-19 in the entire population. The subgroup analyses were done because it is critically 

important to make sure that efficacy is consistent. Nonetheless, the sample sizes become 

smaller when they split the groups. They expect that as they continue surveillance, they will start 

to see increased rates in all of the groups, or at least increased reported numbers of cases. 

What they can say from this subgroup analysis for which the study was not sufficiently powered 

is that the observed efficacy in the various groups was highly consistent with the primary 

efficacy analysis. In terms of the facial swelling, there were 3 cases that occurred in women who 

had previously had injections of hyaluronic acid for a plastic surgery procedure. Facial swelling 

was noted after vaccination, which resolved after treatment with Benadryl® and other supportive 

therapy.

Dr. Atmar asked whether any generalized skin reactions were observed other than the facial 

swelling and the localized reactions, how many participants had a history of anaphylaxis, how 

long protection after vaccination may last, and what Moderna’s plans are for examining duration 

of protection and the need for a booster beyond the 2 to 3 months of information they have postcompletion of the vaccine series. 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Dr. Miller indicated that there were some reports of rash throughout the study in the unsolicited 

AEs. The rashes that were in balance between the vaccine and placebo groups were the 

injection site rashes that were noted in the week after vaccination or soon after vaccination. A 

standardized measure query was run on subjects 48 hours after vaccination and overall, no 

large imbalances were observed between the groups. In terms of the medical histories for 

anaphylaxis, in the overall category of anaphylaxis, allergic events, and autoimmune events, the 

subjects were well-balanced in their medical histories. For the chronic lung disease the 

investigators were specifically seeking, moderate to severe asthma was specifically highlighted 

in the protocol to be of interest. No imbalance was observed between the groups in those 

categories from medical history. In terms of how long protection lasts and future plans, Moderna 

anticipates in the next few weeks to have 6-month antibody persistence data from the Phase 1 

study on which they collaborated with NIH. In both the Phase 2 and Phase 3 studies, there are 

planned antibody persistent time points at 3 months, 6 months, and 12 months after vaccination. 

That follow-up will continue for 2 years after vaccination in the Phase 3 study. They are currently 

discussing the potential for conducting 6-month boosters in the Phase 2 study, the rationale for 

which is to be able to vaccinate a naïve cohort and then assess the cohort that received the 

100μg dose to determine whether they are able to boost to the vaccine. They also intend to 

examine antibody kinetics at approximately 1 week after vaccination in order to ensure that 

there is an immune memory response. Moderna should be able to provide more information 

about persistence and boosting in the coming months.

Dr. Sanchez asked whether Moderna is assessing women who are lactating/breastfeeding in 

terms of any effects on the neonate and infant pertaining to protection or abnormalities, how 

many individuals who experienced skin reactions or hypersensitivity required treatment within 

15 to 30 minutes with Benadryl® or epinephrine, and whether individuals who were enrolled who 

had a past history of being seropositive developed another infection. One of the questions that 

keeps arising regards individuals who have had COVID-19 infection previously, the subsequent 

risk of having another possible significant infection, and the vaccination by groups being very 

important information.

Dr. Miller said that Moderna has heard very clearly from its stakeholders that the safety and 

immunogenicity of the vaccine in pregnant women is a topic of clear interest. Now that they 

have observed a positive efficacy signal and a reassuring safety profile in non-pregnant adults 

and the DART animal study has been completed, Moderna is ready to begin considering the 

clinical study design in pregnant women and their children. There are many important 

considerations including breastmilk and follow-up in the infants. From the DART study, the 

investigators observed a robust immune response in the mother rats. There also was 

transplacental transfer of antibodies to the pups. Therefore, Moderna would definitely be 

interested in looking at the antibody transfer to young infants. In the report that Dr. Miller read, 

no malformations or abnormalities were observed in the dams or pups. While she could not 

speak to the placenta, it was not highlighted in the findings of the report. Regarding the 

reactions that occurred within the first 30 minutes after vaccination, that was the population on 

which the standardized Medical Dictionary for Regulatory Activities (MedDRA) query was 

conducted for anaphylaxis. They found that symptoms were sometimes reported with other 

allergic reactions. All 4 reactions were non-serious Grade 1 to 2 in severity and they did receive 

Benadryl® or prednisone in some cases and all resolved. No epinephrine was administered and 

there were no hospitalizations. In terms of the injection site reactions, some occurred within the 

7-day duration period and some outside of it. One individual developed a COVID-19 infection 

after participating in the trial who was randomized to the mRNA-1273 group but received 

placebo and unfortunately developed a second infection while on trial. An overall efficacy 
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analysis was performed and while it was on a relatively small proportion of the group, it was not 

inconsistent with the overall efficacy analysis. An analysis was done on the full analysis set that 

considered everybody at the time of randomization, did not consider whether they got their 

vaccination according to their assigned treatment group, and included the entire population not 

just the 2% who were seropositive. The overall efficacy was 93.6%.

Dr. Talbot inquired about the age range of the Bell’s Palsy cases, noting that it is common for 

adults to have Bell’s Palsy but that it would be very helpful to determine whether the age of 

Bell’s Palsy was shifted lower in the trial.

Dr. Miller indicated that the cases of Bell’s Palsy occurred in subjects 30, 52, 67, and 72 years 

of age.

Dr. Bernstein recalled hearing that pediatric studies would be going down to 6 months of age, 

and inquired as to when data would be available on individuals 12 to 17 years of age. He 

emphasized the importance of Moderna assessing this as the Pfizer product currently goes 

down to 16 years of age.

Dr. Miller indicated that they need to have discussions about how much data would be sufficient 

to evaluate the potential to lower the age indications of the vaccine, understanding that 

vaccinating children will be very important for getting them back to school and protecting 

educators. Given that Moderna has not yet had the opportunity to speak to the FDA about this, 

she said she would not be able to comment further at this time.

Ms. Bahta requested information about any impact from deviation from the 28 days between the 

2 doses or delayed doses, and whether there are any details about the rates of AEs by race and 

ethnicity.

Dr. Miller indicated that protocol allowed subjects to come in between Days 26 to Day 36. Likely 

due to disruptions from COVID-19, they found a relatively significant number of individuals who 

came in as early as 1 week prior or 3 weeks after Dose 1 and as much as 2 weeks after Dose 2 

or 6 weeks out from the final dose. That 3 week span formed the basis of the per protocol 

analysis. They have not analyzed specifically by when cases may have occurred based on 

when people may have been vaccinated. Referring to Slide 56, she indicated that there are 

some details of rates of AEs by race and ethnicity. Overall in this subgroup analysis, the 

estimates of efficacy were consistent with the primary analysis though the sample size is small. 

They did not observe that one racial group had a particularly higher reported incidence of AEs 

than other racial groups. The pattern of reporting was consistent as well.

Dr. Goldman (ACP) reported that with the Pfizer vaccine, they are seeing that there is some 

overfill of the multi-dose vial, which potentially results in the ability to get 1 to 2 more doses out 

of the vial. He wondered whether this would be the same with the Moderna vials and what the 

recommendations would be if there is overfill and potential extra doses in the vial in terms of 

whether the extra could be used or should be wasted.

Dr. Miller responded that with every liquid vaccine, there is always overfill because there is 

always extra material in the vial in the stopper and the needle of the syringe.

Dr. Altaris added that each container of injectable product is filled with a volume that slightly 

exceeds the content indicated in the labeling. The Moderna product labeling states 10 doses 

and the excess volume is really meant to be sufficient to permit withdrawal and administration of 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

19

the labeled volume. Several studies were conducted to define the most appropriate fill volume 

for the Moderna product to allow the 10 doses to be withdrawn. They do not anticipate that most 

users will be able to withdraw more than 10 doses using typical syringes and needles. 

Occasionally, there might be some very skilled individuals who might be able to withdraw an 

11th dose if they withdraw doses very carefully. However, this is not anticipated to be common 

given the fill volume that was optimized. In the EUA fact sheet, there is no claim of how many 

doses an individual can actually remove. FDA has advised previously that all doses could be 

utilized.

Dr. Cohn indicated that this would be a further discussion on the second day of the ACIP 

meeting as well.

Dr. Fryhofer (AMA) observed that VE on Slide 21 of 94.1% overall is fabulous but VE for 

patients ≥ 65 years of age with or without comorbidities was 86.4% and for those 65 to < 70 

years of age with or without comorbidities was 82.4%. She asked about the timing between 

patients receiving dermal fillers and vaccine injections, inquired about the theoretical reason that 

patients previously having COVID-19 reacting less to the vaccine, and wondered whether the 

mRNA crossed the placenta in the DART study.

Dr. Miller said she was not aware that the DART study specifically looked for the mRNA to cross 

the placenta. The reason for that is that mRNA is naturally broken down. The data investigating 

the platform suggests that after 2 days, the mRNA is completely degraded.

Dr. Martin indicated that 4 AEs were reported in mRNA-1273 participants who received filler 

injections between 13 days and more than 6 months prior to vaccine, with 1 dermal filler of 

unknown duration before vaccination. All resolved except 1 Grade 1 AE that was resolving last 

they heard.

Dr. Rockwell (AAFP) asked whether any of the study participants had comorbidities with cancer

and treatment for cancer such as chemotherapy and if so, whether Moderna has any data on 

that.

Dr. Miller indicated that subjects in this trial were excluded if they had a known cause of 

immunosuppression. That said, a few subjects were enrolled who had baseline stable 

conditions such as chronic lymphocytic leukemia (CLL). To her knowledge, none were on active 

chemotherapy. The reason for engaging in the NCI collaborative study is to assess the vaccine 

in those subjects.

Ms. Stinchfield (NAPNAP) asked what the recommendation would be for repeating that injection 

if there is a mishap at the time of injection and some of the product is lost and if so, whether it 

should be at the same site or at a different site.

Dr. Miller indicated that the vaccine has been studied in a 2-dose schedule. Other than in 15 

subjects in the NIH study, they have not studied doses higher than 100μg. In the absence of 

those data, she suggested deferring that question to CDC and perhaps discussing later in the 

afternoon.

In terms of asymptomatic carriage, Dr. Sanchez asked whether the 14 subjects who were 

positive before Dose 2 from routine screening were associated with any decreased antibody 

responses and if this had been correlated with other markers that could help determine which 

individuals actually may be carriers.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Dr. Miller said that they have not yet received and fully analyzed their immunogenicity data, but 

that certainly would be an interesting additional analysis for Moderna to conduct.

Dr. Poehling requested additional information about the number of cases of appendicitis in the 

vaccine and placebo groups, when they occurred, and whether any differences were observed.

Dr. Miller indicated that there were 2 cases of appendicitis reported as an SAE in the vaccine 

group and 3 cases in the placebo group.

Dr. Whitley-Williams (NMA) pointed out that sometimes rashes may not be that evident on 

people of darker skin color and she urged Moderna to pay close attention to this symptom as 

more doses are dispensed. She also applauded them for assessing the occurrence of SAEs 

and any AEs and requested that any disproportionate occurrence of any AE be brought to light, 

particularly as it affects people of color. The message is getting out and people of color are 

increasingly expressing interest in getting the vaccine. One way to stay on the right path is to 

ensure that monitoring continues for AEs. Obviously, 10% enrollment in the trials is better than 

1%. However, the numbers are still small so some events may not be seen until 10,000 to 

20,000 people of color are immunized. 

Dr. Miller completely agreed that this is a place to start and is a platform upon which they can 

improve, and said that she was thrilled to hear that people from communities of color are 

interested in being vaccinated.

Observing that there are reports from public health agencies in the United Kingdom (UK), South 

Africa, and a Canadian province that a new strain has emerged, Dr. Shah (ASTHO) inquired as 

to whether there was any sense about, or at least a theoretical approach for, how the mRNA1273 vaccine’s efficacy might be evaluated against the possibility of a new strain and how the 

vaccine may behave in such situations.

Dr. Miller emphasized that this is a constantly changing pandemic that has kept everyone “on 

their toes” throughout the entire process. Moderna has been looking into this question and has 

evaluated the ability of sera to neutralize some of those mutant strains. She invited Dr. Moore to 

share more details about those experiments.

Dr. Moore added that Moderna is actively looking at all of the mutant strains that are emerging. 

They have sera from the rodents and NHPs that were immunized in the animal studies that is 

being tested against the emerging strains. So far, they have found that the animal sera 

neutralized all of the emergent strains they have tested. They also will be testing for 

neutralization using the human sera being collected as part of the trial. Deep sequencing will be 

done for any breakthrough cases in the clinical trial to assess the mutation status of those 

viruses. 

Referring to Slide 25 looking at the asymptomatic infection, Dr. Howell (AIM) asked whether 

Moderna has cycle thresholds on those individuals and whether there was any difference 

between the vaccine versus the placebo groups.

Dr. Miller indicated that she did not have the cycle threshold data readily available, but would 

report that information back to the group later.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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GRADE: Moderna COVID-19 Vaccine

Julia Gargano, PhD, MS

Epidemiologist

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Gargano presented the GRADE evaluation of the Moderna COVID-19 vaccine. The policy 

question under consideration is, “Should vaccination with Moderna COVID-19 vaccine 

be recommended for persons 18 years of age and older under an Emergency Use 

Authorization?” The components of the Population, Intervention, Comparison, Outcomes (PICO) 

question include a population under consideration of persons aged ≥18 years, an intervention of 

2 doses of the Moderna COVID-19 vaccine given intramuscularly (IM) at 28 days apart, a 

comparison of no COVID-19 vaccine, and the 7 outcomes identified by the WG as the most 

important for the policy question are listed here: 

 

 Symptomatic laboratory-confirmed COVID-19 

 Hospitalization due to COVID-19 

 All-cause death 

 SARS-CoV-2 seroconversion to a non-spike protein 

 Asymptomatic SARS-CoV-2 infection 

 Serious adverse events 

 Reactogenicity Grade ≥3

The potential benefits include prevention of symptomatic COVID-19 and hospitalization due to 

COVID-19, which both were considered critical outcomes; and all-cause death, SARS-CoV-2 

seroconversion, and asymptomatic infection is identified as important. The 2 harms identified 

were SAEs as a critical outcome and reactogenicity Grade 3 or 4 as an important outcome. Of 

note, in the case of current COVID-19 Phase 3 vaccine trials, hospitalization due to COVID-19 

and deaths are less common and the trials may not be designed or powered to evaluate 

differences between treatment groups. The WG did not necessarily expect to have robust direct 

evidence for these outcomes at this point, and to some degree could infer that decreases in 

symptomatic COVID also would translate to decreases in hospitalizations and deaths, as has 

been observed for other vaccines. For the outcome of asymptomatic infection assessed using 

serial polymerase chain reaction (PCR) testing, data from one time point were assessed and 

these were included in the evidence profile as preliminary evidence. Finally, for the outcome of 

seroconversion, no data are currently available, so this could not be included in the evidence 

profile Dr. Gargano presented. Data on seroconversion eventually will be available in an 

ongoing Phase 3 trial.

A systematic review was conducted to identify evidence related to the policy question.

Published articles were identified using the databases and search terms listed here to identify 

relevant published literature: coronavirus, COVID-19, SARS-CoV-2, respiratory (symptom, 

disease, illness, condition), vaccine, immunization, trial, double blind, single blind, placebo, 

comparative study, Phase 3, immunogenicity, efficacy, effective, adverse, evidence, and 

variations on these terms. Additional resources were sought, including obtaining unpublished 

data from vaccine manufacturers. Briefly, over 2800 records were identified through database 

searching and records for two studies were obtained directly from the trial sponsor. Ultimately, 4 

studies were included in the evidence synthesis. Additional information on the identified studies 

was included from FDA materials prepared for the VRBPAC.
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GRADE evidence type assesses the certainty of the estimates from the available data and are 

as follows:

 Type 1 (high certainty): Very confident that the true effect lies close to that of the estimate 

of the effect.

 Type 2 (moderate certainty): Moderately confident in the effect estimate. The true effect is 

likely to be close to the estimate of the effect, but there is a possibility that it is substantially 

different.

 Type 3 (low certainty): Confidence in the effect estimate is limited. The true effect may be 

substantially different from the estimate of the effect.

 Type 4 (very low certainty): Very little confidence in the effect estimate. The true effect is 

likely to be substantially different from the estimate of effect.

It is important to note that the evidence type is not measuring the quality of individual studies, 

but instead is measuring how much certainty there is in the quantitative estimates of effect 

across each outcome. The initial evidence type is determined by the study design. A body of 

evidence from randomized controlled trials (RCTs) starts with an initial evidence type of 1,

indicating high certainty. A body of evidence from observational studies starts with an evidence 

type of 3, indicating low certainty. The evidence type can be downgraded due to risk of bias, 

inconsistency, indirectness, or imprecision. Other considerations could downgrade or upgrade 

the evidence type.

To review the evidence for the benefits, for the critical outcome of symptomatic COVID-19, one 

study provided data. This was the Moderna Phase 3 RCT. Data were obtained directly from the 

sponsor and from FDA briefing documents. The primary data cutoff date was November 25, 

2020, but some analyses were only available from the planned interim analysis conducted using 

the November 11, 2020 cut-off date. A total of 30,351 adults were randomized 1:1 to receive 

either the vaccine or a saline placebo. Analyses were performed using different data sets. The 

full analysis set included all randomized participants who received at least one dose, analyzed 

according to the group to which they were randomized. The mITT set excluded persons with 

immunologic or virologic evidence of prior SARS-CoV-2 infection at day 1 before the first dose. 

The per protocol set included persons from the mITT set who received both planned doses 

according to schedule and had no major protocol deviations. The sponsor used this per protocol 

set for primary efficacy analyses.

Using the per protocol population, for all persons aged at least 18 years, there were 11 cases 

among 14,134 persons in the vaccine arm and 185 cases among 14,073 persons in the placebo 

arm. This resulted in a VE estimate of 94.1% and a 95% confidence interval of 89.3% to 96.8%. 

This is the outcome that was used for GRADE. VE also was at least 86% in various subgroups, 

including those aged 65 and older, 75 and older, and those “at risk” due to presence of a 

comorbidity including severe obesity. Comparing the primary outcome with some secondary 

outcomes, efficacy remained high when persons with evidence of prior infection were included 

and when a broader list of symptoms was used to define COVID-19. In terms of a few post-hoc 

interim analyses, in the mITT in an analysis that was restricted to persons who received only 1 

dose of vaccine or placebo and had no evidence of prior SARS-CoV-2 infection, there were 7 

cases reported among 996 persons who received 1 dose of the vaccine and 39 cases among 

1079 persons who received one dose of the placebo, for a 1-dose short-term VE estimate of 

80.2% and a 95% confidence interval of 55.2% to 92.5%. In the full analysis set, which did not 

exclude people with evidence of prior infection and included everyone who received at least 1 

dose, the efficacy point estimate was 87.9% using all available follow-up post-dose 1. However, 

it must be recognized that the vast majority received the second dose. Censoring the analysis at 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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dose 2, the 1-dose efficacy estimate using the full analysis set with 28 days of follow-up was 

69.5%.

In terms of the GRADE evidence table for the outcome of symptomatic COVID-19, because the 

data were from an RCT, the evidence type started at 1. Regarding risk of bias, there was some 

concern related to blinding. Participants and study staff were blinded to assignments, but they 

may have inferred receipt of vaccine or placebo based on reactogenicity. This was deemed 

unlikely to overestimate the efficacy results. Therefore the risk of bias was considered to be “Not 

Serious” for this and subsequent outcomes. Some concern for indirectness to the outcome was 

noted due to the short duration of observation in the available body of evidence. The VE 

observed at a median 2-month follow-up may differ from the efficacy observed with ongoing 

follow-up. However, in consideration of the strength of association and precision observed for 

this outcome in particular, it is unlikely that the efficacy estimate for symptomatic COVID-19 

would change substantially enough to fall below the FDA-defined efficacy threshold for licensure 

under an EUA to <50% efficacy. The WG also acknowledged some concern for indirectness to 

population because of exclusions from the clinical trial. This was judged to be “Not Serious” in 

part because all available subgroup evaluations were consistently quite high. The relative risk of 

0.06 with a 95% confidence interval of 0.03 to 0.11 indicated a strong and precise estimate. 

There were no other serious concerns affecting the certainty assessment. The level of certainty

was assessed as high, or type 1, for this critical outcome.

The second outcome for consideration was hospitalization for COVID-19. The protocol included 

a definition of severe COVID-19 per FDA guidance of a COVID-19 case with ≥1 of following:

 Clinical signs at rest indicative of severe systemic illness a

 Respiratory failure a

 Evidence of shock a

 Significant acute renal, hepatic, or neurologic dysfunction

 Admission to an intensive care unit

 Death 

This did not require hospitalization. Additional data on severe cases, including hospitalizations, 

was obtained from FDA documents. Of note, one severe case leading to hospitalization in a 

vaccine recipient was included in the analysis that was adjudicated after the November 25, 2020

data cutoff date. The sponsor indicated that hospitalization due to COVID-19 was not 

specifically ascertained for all cases, and it is possible that hospitalizations for COVID-19 in 

cases that did not meet the FDA’s definition occurred and were not captured.

In terms of the analyses of both severe COVID-19 using the protocol definition and 

hospitalization for COVID-19, about two-thirds of persons meeting the severe COVID-19 

definition were not hospitalized. For severe COVID-19, there was 1 severe case in the 

vaccinated group and 30 in the placebo group. The efficacy estimate was 97%, with a 95% 

confidence interval of 76% to 100%. For hospitalization due to COVID-19, there was 1 case in 

the vaccine group and 9 in the placebo group. The efficacy estimate was 89%, with a 95% 

confidence interval of 13% to 99%. This wider confidence interval reflects the smaller number of 

events, but is still statistically significant. The analysis of hospitalizations due to severe COVID19 is the one used in GRADE as it aligns with the PICO-specified outcome. Regarding the

GRADE evidence table for hospitalization for COVID-19, the initial evidence type of 1 was 

downgraded 1 point due to serious concern over indirectness of outcome because of use of a 

subset of cases defined as severe using a set of protocol criteria which may miss some 

hospitalized cases, and the short duration of follow-up. COVID-19 leading to hospitalization 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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measured in such a short time frame is an indirect measure. Some hospitalizations may not

have occurred yet for some cases included in the analysis, and the WG ideally would like to 

observe efficacy for preventing over a longer follow-up period. The final certainty estimate for 

the outcome of hospitalization for COVID-19 is Type 2.

The next outcome of interest was all-cause death, which the sponsor regarded as descriptive 

only. All-cause death was not an efficacy endpoint in the trial protocol, although death due to 

COVID-19 was. There were few deaths among trial participants, including 6 among vaccinated 

persons and 7 among placebo recipients. No person-time analysis of deaths for all-cause death

was provided, and the denominators are based on the safety population of persons who 

received at least one dose. The available data indicates a relative risk of death of 0.86, with a 

95% confidence interval of 0.29 to 2.55. Of note, there was 1 death attributed to COVID-19 

during the available follow-up and it was in a placebo recipient. Regarding the GRADE evidence 

table for all-cause death, no serious risk of bias was identified and there was no serious concern 

of inconsistency. There was serious concern for indirectness due to the short duration of followup. Deaths due to COVID-19 may not have had time to occur during the follow-up period. There 

was very serious concern of imprecision. The relative risk of 0.86 favored vaccination, but the 

very wide 95% confidence interval did not rule out harms. The certainty estimate was Type 4.

The Phase 3 trial provided some preliminary data regarding the outcome asymptomatic SARSCoV-2 infection. The WG intended this outcome to be assessed longitudinally through serial 

PCR testing or other repeated laboratory assessment. As part of the trial protocol, a 

nasopharyngeal swab was collected for PCR testing for SARS-CoV-2 DNA at each vaccination 

visit. In the per protocol analysis, these were used along with serology data to exclude persons 

with evidence of prior SARS-CoV-2 infection from the primary efficacy analyses. The sponsor 

used data on results of the dose 1 and dose 2 PCR tests, along with symptom data collected 

between doses 1 and 2, to construct a measure of asymptomatic infection on the day of the 

second vaccine dose. Using the data this way was not a pre-defined protocol objective.

Regarding the data on the outcome of asymptomatic SARS-CoV-2 infection at dose 2, defined 

as a PCR-positive nasal swab at dose 2 and no symptoms of COVID-19 during the interval 

between doses 1 and 2, there were 14 asymptomatic infections in the vaccine group and 38 

asymptomatic infections in the placebo group for a relative risk of 0.37 and a 95% confidence 

interval of 0.20 to 0.68. This provides preliminary evidence that the vaccine may prevent 

asymptomatic infections after the first dose. While encouraging, there are limitations to this 

analysis. This is a snapshot of one day, it is not clear from the available data whether persons 

who tested positive without symptoms might have subsequently developed COVID-19 

symptoms, and may have been “pre-symptomatic” rather than truly asymptomatic. Also, this 

only shows the effect of the first vaccine dose. Regarding the GRADE evidence table for 

asymptomatic infection, the certainty of the estimate was graded down one point due to serious 

risk of bias due to selective outcome reporting. Certainty was downgraded a further two points 

due to very serious concern for indirectness. The relative risk of 0.37 favored vaccination. The 

certainty estimate was Type 4.

Turning to the data on GRADE for harms, there were 3 studies in addition to the RCT already 

described that provided data on harms. These include an unpublished Phase 2 RCT and 2 

published Phase 1 dose-escalation, open-label studies. First, safety data were included from the 

Moderna Phase 3 RCT. The safety set included all randomized participants who received at 

least one dose of vaccine or placebo and contributed any solicited adverse reaction data. The 

analysis was done according to the intervention actually received. The Phase 2 trial included 

200 persons vaccinated with 2 doses of Moderna vaccine and 200 persons who received 2 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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doses of the placebo. The Phase 1 study by Jackson included data on adults aged 18-55, 

including 15 who were vaccinated with the relevant dose. Finally, the Phase 1 study by 

Anderson included data on adults aged >55 years, including 20 who were vaccinated with the 

relevant dose.

In terms of the raw data on the critical outcome of SAEs, no SAEs were identified from the 

Phase 1 and Phase 2 trials. In the Phase 3 trial, there were 147 events among the vaccine 

group and 153 among the placebo group. Of note, the GRADE analysis relied on a pooled 

analysis of the 2 placebo-controlled studies. Regarding the GRADE evidence table for SAEs, 

there was a balance of SAEs reported among vaccinated and placebo, with a relative risk of 

0.96 and a 95% confidence interval of 0.77 to 1.20. The certainty assessment was reduced 1

point due to serious concern of indirectness of outcome because the body of evidence does not 

provide certainty that rare SAEs were captured due to the short follow-up and sample size, so 

the final certainty was Type 2.

Reactogenicity was evaluated using the same 4 studies. Both RCTs used the same events and 

grading scales shown here:

 Local reactions (pain at injection site, redness, swelling, axillary swelling/tenderness):

 Grade 3: pain at injection site or axillary swelling/tenderness that prevents daily 

activity or use of prescription pain reliever; redness > 10 cm; and swelling > 10 cm 

 Grade 4: emergency room visit or hospitalization for severe pain at the injection site 

or axillary swelling/tenderness, necrosis (redness and swelling categories) or 

exfoliative dermatitis (redness category only).

 Systemic events (fever, nausea/vomiting, headache, fatigue, chills, muscle pain, joint pain):

 Grade 3: fever >38.9°C to 40.0°C , vomiting that requires IV hydration; fatigue, 

headache, chills muscle pain, or joint pain that prevents daily activity.

 Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, diarrhea, or 

vomiting that require an emergency room visit or hospitalization.

The local reactions solicited for the 7 days following vaccination were injection site pain, 

redness, swelling, and axillary swelling or tenderness. The systemic events solicited were fever, 

nausea and vomiting, headache, fatigue, chills, muscle pain, and joint pain. Grade 3 or 4 local 

reactions or systemic events were reported in 5% and 6.7% of vaccinated subjects in the Phase 

1 studies. For the Phase 2 study, reactions were reported in 16% of vaccinated and 3% of the 

placebo group. In the Phase 3 study, Grade 3 or 4 reactions were reported by 21.6% of 

vaccinated and 4.4% of the placebo group. Again, GRADE was conducted using a pooled 

analysis of the Phase 2 and 3 studies. The pooled relative risk for any Grade 3 or 4 event was 

of 4.93 with a 95% confidence interval from 4.55 to 5.34. There was no serious concern for risk 

of bias, inconsistency, indirectness, or imprecision for this outcome. The final certainty was type 

1.

To summarize the WG’s current GRADE assessment for the Moderna COVID-19 vaccine. In 

terms of benefits, the available data indicate that the vaccine prevents symptomatic COVID-19, 

with an evidence type of 1. The vaccine also prevents COVID-19 resulting in hospitalization. For 

this outcome, certainty was reduced due to indirectness and the evidence type was 2. For allcause death, the available evidence slightly favored the intervention, but certainty was reduced 

for indirectness and imprecision and the evidence type was 4. No data were available to assess 

seroconversion. The available data was consistent with a lower incidence of asymptomatic 

SARS-CoV-2 infection in the vaccinated group, but certainty was reduced for risk of bias and 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

26

indirectness, and certainty was type 4. In terms of harms, the available data indicate that SAEs 

were balanced between the vaccine and placebo arms, and 3 SAEs were judged to be related 

to vaccination among over 15,000 persons vaccinated. Severe reactions were more common in 

vaccinated persons, and about 22% of vaccine recipients vs. 4% of placebo recipients reported 

Grade 3 or 4 reactions. The evidence type was type 1, indicating high certainty in the estimate.

To conclude, Dr. Gargano put the GRADE into the context of the policy question, which focuses 

on an interim recommendation issued under an EUA. Regarding benefits, the Phase 3 trial is 

ongoing and effect estimates may change with additional follow-up. This raised concern for 

indirectness of outcome, as ideally the WG would like to observe efficacy over a longer period 

than 2 months median. They judged that it is unlikely that the efficacy estimate for symptomatic 

COVID-19 would change substantially enough in the months following vaccination to fall below 

the FDA-defined efficacy threshold for an EUA, but indirectness remained a serious concern for 

some other outcomes. Direct evidence of efficacy for hospitalization and deaths is limited at this 

time due the small number of events that had been observed through the cutoff date. From the 

efficacy against symptomatic disease, the WG inferred that vaccination also would reduce 

hospitalizations and deaths. Preliminary data were consistent with an effect the vaccine 

preventing asymptomatic infections. Regarding harms, Grade 3 reactions were not uncommon 

in vaccinated persons. SAEs occurred at a similar frequency in vaccine and placebo groups, but 

only 3 SAEs were associated with vaccination.

EtR Framework: Moderna COVID-19 Vaccine 

Sara Oliver MD, MSPH 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Oliver reminded everyone that the EtR framework provides structure that moves ACIP from 

evidence to ACIP vaccine recommendations and highlighted updates based on the Moderna 

COVID-19 vaccine. The policy question being addressed was, “Should vaccination with the 

Moderna COVID-19 vaccine (2-doses, IM) be recommended for persons 18 years of age and

older under an Emergency Use Authorization?” She reviewed the PICO question detailed in the 

GRADE presentation and shared a table to remind everyone of the EtR domains (Public Health 

Problem, Benefits and Harms, Values, Acceptability, Feasibility, Resource Use, and Equity) and 

put each one into the context of the Moderna vaccine and COVID-19 disease.

The public health problem domain addressed the primary question of, “Is COVID-19 disease of 

public health importance?” Every time the WG has presented these data, the report on overall 

and daily case count becomes more somber. As of December 17th, there had been nearly 17 

million cases with a 7-day moving average of over 215,000 cases a day. As of December 17th, 

nearly 310,000 COVID-19 deaths reported to CDC with a 7-day moving average of 2,600 

deaths per day. The cumulative hospitalization rate between March and December 12th, was 

295 per 100,000 population. Among those hospitalized, nearly 1/3 required intensive care and 

15% died. The case fatality range is from 0.5 to 1.4%. The WG judgment is that yes, COVID-19 

disease is of public health importance.
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The benefits and harms domain addressed the primary questions of, “How substantial are the 

desirable anticipated effects?” “How substantial are the undesirable anticipated effects?” and 

“Do the desirable effects outweigh the undesirable effects?” The detailed review of the benefits 

and harms through GRADE were just presented. Dr. Oliver walked through highlights and some 

additional information. The clinical trial demonstrated high efficacy against the primary endpoint 

of symptomatic laboratory-confirmed COVID-19 with an efficacy of 94.1%. This was determined 

to have a high certainty related to the policy question under an EUA. For hospitalizations, 10 

events occurred. Of those, 9 were in the placebo group and 1 was in the vaccine group. VE 

against hospitalizations was estimated at 89%. Given the low numbers and short time of followup, there was moderate certainty in this assessment. For all-cause mortality, deaths were 

uncommon overall, with 6 in the vaccine group and 7 in the placebo group. Given the low 

numbers, there was uncertainty in the evidence for this outcome.

The ability of the vaccine to prevent asymptomatic SARS-CoV-2 infection has not been 

assessed to date in a large, prospective trial using serial PCRs. However, the ability of the 

vaccine to prevent asymptomatic infection could be informed by PCR screening among trial 

participants returning for a second dose. Four weeks after the first dose of the Moderna COVID19 vaccine, 14 (0.1%) had a positive PCR without symptoms of COVID compared to 38 (0.3%)

of those receiving placebo. Again, this one-time point prevalence does not follow people over 

time and it is only after the first dose. Protection against asymptomatic infection before or after 

this time point is unknown. Given all of these caveats, there was low certainty of the evidence. 

However, it is encouraging and the WG looks forward to additional data points to inform this 

outcome.

For a further summary of benefits, in addition to the efficacy of 94.1% for the primary endpoint, 

high efficacy was found for additional analyses across age, sex, race, and ethnicity categories 

and those with underlying medical conditions. Efficacy among adults 18 to 64 years was 95.6% 

and among adults ≥65 years of age was 86.4% with wide confidence intervals. To emphasize 

that these specific estimates are based on small numbers in the trials, there is some variation 

during the exact population or age cutoff. The efficacy among adults ≥75 years of age was 

100%. Most recipients received 2 doses of the Moderna vaccine. That efficacy was estimated at 

69.5% between Dose 1 and Dose 2. Thirty cases of severe disease were noted in the placebo 

group and 1 in the vaccine group yielding a VE estimate of 97%, The numbers of observed 

COVID-19-associated hospitalizations or deaths were low. However, the trend was consistent 

with 9 of 10 hospitalizations and the 1 COVID-associated death occurring in a placebo 

recipients.

To summarize possible harms, SAEs were reported in a similar proportion among recipients of 

vaccines and placebo. There was moderate certainty in this evidence. The reactogenicity 

outcome graded was severe or Grade 3 or more reaction. Overall, a Grade 3 or higher reaction 

was reported by 21.5% of those receiving the vaccine versus 4.4% of the placebo group. This 

was graded with a high certainty of evidence. Local reactions occurring within 7 days were 

common. Pain at the injection site was the most common. Systemic reactions within 7 days 

were common as well with fatigue, headache, and myalgias as the most common. Symptom 

onset was usually 1 to 2 days post-vaccination and most symptoms resolved in a median of 2 to 

3 days.
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To highlight the select local reactions by dose in 2 populations of persons aged 18 to 64 years

of age and person ≥65 years, the proportion of participants who received the Moderna vaccine 

who reported any local reaction was 75% or over. However, 15% to 20% of those receiving 

placebo reported a local reaction as well. For any systemic reactions and report of fever in the 

younger and older population, around half of vaccine recipients reported any systemic reaction 

after the first dose and 70% to 80% percent reported a systemic reaction after the second dose.

However, 30% to 45% of recipients who received the saline placebo also reported a systemic 

reaction after the first or second dose. Reports of Grade 3 or Grade 4 fever were rare. As was 

done after the prior EUA, there will be a website summarizing this reactogenicity data after each 

dose on the CDC and ACIP websites to help inform providers and patients about possible 

expected symptoms post-vaccination.

Lymphadenopathy was also noted in the clinical trials. Ipsilateral, or the same side of the 

vaccine, axillary swelling and tenderness was a solicited AE in the trials, which differs from what 

was discussed last week. This ipsilateral axillary lymphadenopathy was more common among 

vaccine recipients less than 65 years of age occurring among 21% of participants. Grade 3

axillary lymphadenopathy was rare but slightly more common after the second dose. 

Adenopathy was noted to last a median of 1 day after the first dose and 2 days after the second

dose. As localized lymph nodes are involved in the vaccine response, it is plausible that this 

could be related to the vaccine.

Regarding Bell’s Palsy, there was a small imbalance between the vaccine group with 3 reports 

compared to 1 in the placebo group. Currently available information is insufficient to determine a

causal relationship with the vaccine. Post-authorization surveillance will be important to help 

determine any possible causal relationship moving forward. As has been highlighted previously, 

SAEs were similar between vaccine and placebo groups, with no meaningful imbalance 

between the groups for any specific conditions.

Overall, the WG felt that the desirable anticipated effects were large and that the undesirable 

anticipated effects were small. Based on this, the WG felt that considering how the desirable 

effects balance with the undesirable effects, it favors the intervention of the Moderna COVID-19 

vaccine.

The values domain addressed the primary questions of, “Does the target population feel that the 

desirable effects are large relative to the undesirable effects?” and “Is there important 

uncertainty about, or variability in, how much people value the main outcomes?” In terms of the 

details of the methods, which have been presented before, the search was updated through 

December 18, 2020. The proportion intending to receive the vaccine ranged from 40% to 86%. 

In a recent survey, 40% reported that they would receive the vaccine as soon as possible, 44%

plan to receive the vaccine but wanted to wait a bit, and 15% said they would not receive the 

vaccine. Taking into account people willing to receive the vaccine now and after a brief wait,

84% were willing to take a COVID-19 vaccine. Combining the data from 33 surveys, the surveys 

in December reported a broad range of vaccine acceptance.

To summarize the available evidence for values, many adults report intentions to receive a 

COVID-19 vaccine with increasing willingness over the past several weeks. Intentions varied 

substantially by race or ethnicity and socioeconomic status. The WG interpretation of the first 

question regarding whether the target population feels that the desirable effects are large, the 

WG felt that the answer was probably yes, but likely would vary by population and over time.

The WG also felt that there was probably important uncertainty or variability in how people value 

the main outcomes.
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The main question for the domain of acceptability is, “Is the Moderna COVID-19 vaccine 

acceptable to key stakeholders?” A review of the literature was conducted and this information 

has all been presented previously. There has been no new published information since last 

week; however, the media reports over the last week have highlighted numerous HCP receiving 

their COVID-19 vaccine. One news report showed that at that hospital, only 2 had declined or 

deferred vaccination. Acceptability generally focuses on vaccination stakeholders, the persons 

providing the vaccines. However, in this instance, the stakeholders, HCP, are also the patients

and vaccine recipients. While it was previously highlighted that jurisdiction had submitted 

implementation plans, jurisdictions are now implementing vaccination plans. Pharmacy chains 

are working to launch the COVID-19 vaccine program in long-term care facilities (LTCF). The 

WG felt that the Moderna COVID-19 vaccine was probably acceptable to key stakeholders.

The feasibility domain asks, “Is the Moderna COVID-19 vaccine feasible to implement?” The 

barriers to implementation discussed by the WG included financial barriers, complexity of 

recommendations, and vaccine storage and handling requirements. For financial barriers, 

COVID vaccines will be provided free of charge. However, health systems or health 

departments could incur costs for vaccine implementation or clinics. For complexity of 

recommendations, 2 mRNA vaccines under an EUA with different dosing intervals as well as 

different storage and handling requirements may make vaccine recommendations more 

complex. For vaccine storage and handling requirements, the vaccine must be maintained at 

standard freezer temperatures for shipping and long-term storage. However, it is stable for up to 

30 days at refrigerated temperatures. The minimum size of orders is currently 100 doses. Both 

of these specifications will have a positive impact on feasibility. However, the requirements of 

the 2-dose series still remain and could impact feasibility for series completion. Overall, the WG 

felt that the Moderna COVID-19 vaccine was feasible to implement.

The primary question for the resource use domain is, “Is the Moderna vaccine a reasonable and 

efficient allocation of resources.” There are no new data on the estimated costs associated with 

COVID-19 disease, but the estimates remain at hundreds of billions or trillions of dollars. The 

government already has provided billions for the development and manufacturing of vaccines, 

and vaccine doses purchased with US taxpayer dollars will be given to American people at no 

cost. The WG will have more information eventually to conduct the full cost-effective analysis.

However, the WG felt that cost-effectiveness is not a primary driver for decision-making during 

the pandemic. This is an aspect of the EtR that will be re-evaluated with additional data and 

future recommendations. Based on the current situation, the WG felt that yes, the Moderna 

COVID-19 vaccine is a reasonable and efficient allocation of resources.

The primary question for the equity domain is, “What would be the impact of the COVID-19 

vaccine on health equity?” Through systematic process and using the idea of COVID-19, the 

WG identified groups that might be disadvantaged in relation to COVID-19 disease burden or 

receipt of a COVID-19 vaccine. The following populations have been identified and discussed in 

detail at previous ACIP meeting:

 Racial and ethnic minority populations

 People living in poverty or with high social vulnerability

 Essential workers:

 Some racial/ethnic minority populations disproportionately represented in subsets of 

essential workers, e.g., public transit, building cleaning services, construction, food 

and agriculture

 Almost one quarter live in low-income families
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 Residents in congregate settings, such as long-term care facilities, prisons, homeless 

shelters, and group homes for people with intellectual/developmental disabilities

 People with substance abuse disorders

 Sexual and gender minorities, who may face social or structural inequities that can lead to 

health disparities

There are specific characteristics of the Moderna COVID-19 vaccines that could impact health 

equity. There are storage, handling, and administration requirements. This vaccine is 

refrigerator-stable, which will facilitate the ability of the vaccine into more community settings

once supply allows. The need for 2 doses remains a challenge and follow-up will be challenging 

for some disadvantaged groups. Although COVID-19 vaccines will be provided at no cost, a 

personal investment in time and travel to obtain the vaccine may be a barrier for some groups. 

Equity and vaccination program implementation are closely linked. Advancing health equity will 

require efforts to identify and reduce access-related barriers to vaccination among groups to 

experience disproportionate COVID-19-related morbidity and mortality. The WG felt that the 

impact of the COVID-19 vaccine would be to probably increase health equity, especially with 

easier cold chain requirements allowing for broader availability once supply allows.

After reviewing the data, the WG provides a judgment on the balance of consequences selected 

from the following options:

 Undesirable consequences clearly outweigh desirable consequences in most settings

 Undesirable consequences probably outweigh desirable consequences in most settings

 The balance between desirable and undesirable consequences is closely balanced or 

uncertain

 Desirable consequences probably outweigh undesirable consequences in most settings

 Desirable consequences clearly outweigh undesirable consequences in most settings

 There is insufficient evidence to determine the balance of consequences

The WG felt that the desirable consequences clearly outweigh undesirable consequences in 

most settings. In addition, after reviewing the totality of information presented in the EtR 

framework, the WG discussed the type of recommendation proposed to ACIP among the 

options of: 1) Do not recommend the intervention, 2) Recommend the intervention for 

individuals based on shared clinical decision-making, or 3) Recommend the intervention. The 

WG was in agreement based on the data presented that the type of recommendation proposed 

is a full recommendation of the intervention.

The WG proposed the following interim recommendation language for an ACIP vote:

“The Moderna COVID-19 vaccine is recommended for persons 18 years of age and 

older in the US population under the FDA’s Emergency Use Authorization.”

Discussion Points

Dr. Poehling requested specific details about distribution of the vote within the WG.

Dr. Oliver indicated that in terms of the balance of consequences, the overwhelming majority 

said that the desirable consequences clearly outweigh the undesirable consequences in most 

settings. A very small minority felt that the desirable consequences probably outweigh the 

undesirable consequences. The WG was in an agreement based on the type of 

recommendation.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Ms. Bahta made a motion that ACIP recommend the Moderna COVID-19 vaccine for persons 

18 years of age and older under the FDA’s EUA. Dr. Szilagyi seconded the motion. Drs. Atmar, 

Frey, and Hunter were reminded to recuse themselves from any discussion, motion, or vote due 

to their previously stated COIs.

Dr. Romero indicated that a vote would be taken on this motion following the public comment 

session following the presentations by Drs. Clark and Mbaeyi.

Anaphylaxis Following m-RNA COVID-19 Vaccine Receipt

Thomas Clark, MD, MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Clark reviewed clinical considerations for the use of mRNA COVID-19 vaccines in the US. 

On December 8, 2020, the UK initiated its vaccination program with the Pfizer-BioNTech 

COVID-19 vaccine. The following day, UK authorities confirmed 2 cases of anaphylaxis after 

vaccination. As with other vaccines, prescribing information for both Pfizer-BioNTech and 

Moderna COVID-19 vaccines contains information on anaphylaxis, namely that severe allergic 

reaction (e.g., anaphylaxis) to any component of the vaccine is a contraindication to vaccination

and that appropriate medical treatment used to manage immediate allergic reactions must be 

immediately available and used in the event of anaphylaxis.

ACIP considered this prescribing information and the UK reports of anaphylaxis during its

deliberations on Pfizer-BioNTech COVID-19 vaccine during December 11-12, 2020 meeting. On 

December 12, 2020, CDC published clinical considerations for use of Pfizer-BioNTech COVID19 vaccine that included guidance on contraindications and precautions. As of December 18, 

2020, CDC has identified 6 case reports of anaphylaxis following Pfizer-BioNTech vaccine and 

meeting the Brighton Collaboration criteria for anaphylaxis. The cases were Brighton 

Collaboration Levels 1 or 2. Additional case reports have been reviewed and were determined 

not to be anaphylaxis. These cases occurred within the recommended observation window

post-vaccination and were promptly treated. Investigations are ongoing, but it is known that one 

case had a history of anaphylaxis following rabies vaccination. All suspect cases were notified 

through the VAERS or CDC notification processes and in most cases, through multiple 

channels. These case reports are undergoing or will undergo clinical case review by the Clinical 

Immunization Safety Assessment (CISA) project. As of December 19, 2020, a total of 272,001 

doses of vaccine had been reported as administered. Dr. Clark encouraged interpretation of this 

number with caution as it is probably a minimal estimate. Providers are requested to report 

administration within 72 hours to jurisdictions and jurisdictions are to report this within 24 hours 

to CDC.

Since notification of these cases and during the investigation, CDC has been in close 

coordination with FDA and has held discussions with CISA investigators, NIH, the Medicine and 

Healthcare products Regulatory Agency (MHRA) in the UK, allergy and immunology experts, 

and other partners. On December 16, 2020, CDC published “Interim Considerations: Preparing 

for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites.”
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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To provide an update on CDC’s V-Safe active surveillance project, as of December 18, 2020, a 

total of 112,807 people had registered and reported receipt of 1 dose of vaccine. Of those, 3150 

reported an AE that had an impact on their health of either limitation on the performance of 

normal daily activities, going to work, or for which they sought medical attention. Of the total, 

514 recipients reported pregnancy. CDC has mechanisms in place to follow-up medically 

attended reported AEs and extensive follow-up of vaccinated pregnant women.

In summary of CDC assessment and further actions, post-authorization pharmacovigilance 

systems have detected and confirmed 6 anaphylaxis cases following vaccination. These 

notifications received have been timely, mostly within a few hours. Several notifications have 

been ruled, indicating that the systems are sensitive to identifying anaphylaxis. CDC will 

continue to reinforce measures to recognize, respond to, and report anaphylaxis. Persons with 

anaphylaxis following COVID-19 vaccination should not receive additional doses of COVID-19 

vaccine. CDC is working in consultation with allergy and immunology experts to provide further 

guidance on the evaluation of persons following anaphylaxis to COVID-19 vaccine. 

Discussion Points

Ms. Bahta asked whether individuals who have reported health impact events are being 

followed and if so, what is being learned from them.

Dr. Clark indicated that CDC is following up on those. The number has been quite substantial,

so the focus is on those with medically attended AEs since those are of the most interest. He 

did not think they had anything systematically to share yet in terms of results.

Dr. Bernstein asked whether they are able to separate out those that required medical care 

versus those that are just impacting daily activities or the ability to go to work. Dr. Clark clarified 

that they are able to do so.

Dr. Bell inquired as to whether there is any clustering, especially geographically, among these 

cases and any if there are any other aspects that these cases share in order to get a sense of 

what kinds of things might explain this phenomenon.

Dr. Clark said while it is early to share data from ongoing investigations, the persons with 

anaphylaxis have received vaccine from more than one production lot. Multiple lots have been 

distributed and are being used, thought probably not equally. Reports from Alaska have been in 

the news, but CDC has had reports from other jurisdictions so there is no obvious clustering 

geographically.

Dr. Atmar asked whether Dr. Clark could provide an idea about what percentage of the health 

impact events were actually medically attended events and when they might get a more detailed 

report to offer the public.

Dr. Clark said that while he did not have the exact number with him, it is the minority of the 3150

reports. CDC is working diligently to summarize its data and put it out quickly as possible.

Dr. Poehling asked how many of the 6 cases with anaphylaxis were hospitalized and whether 

others had a history of anaphylaxis to things other than rabies vaccine.

Dr. Clark indicated that no others had confirmed anaphylaxis with other medications, foods, or 

other exposures. Investigations are ongoing. Most were hospitalized, treated, and observed.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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They are careful not to describe individual cases. Most vaccination is going on still in hospital 

settings, so people are often being vaccinated in the places they work. All of the individuals are 

adults under the age of 65 years.

Dr. Lee appreciated that the systems that are in place are both sensitive and timely. It is only 

the first week of the vaccination program and CDC is already bringing information to the group. 

She recognized that there is still more work to do in terms of estimating and understanding the 

risks, but to her it does seem qualitatively higher than for most typical vaccines. That does not 

necessarily change the benefit/risk balance of the COVID-19 vaccines at this time for her. It is 

really important to rapidly understand and manage all of the risks that come with vaccinations 

and still make sure that they are providing access to the vaccine to the population. She 

acknowledged that they would learn more as they go and would adapt recommendations and/or 

clinical guidance as needed, and reiterated that this is exactly what is supposed to happen in 

terms of vaccine safety surveillance, making sure that ACIP and the public are aware that all of 

this is continuing to be under investigation and being done in real-time.

Dr. Kimberlin (AAP Red Book) noted that per the reports in the newspapers, several of these 

cases of anaphylaxis occurred at the same hospital while other hospitals had no cases and he 

wondered whether this is unusual.

Dr. Clark emphasized that it is early and they are more sensitive to this potential risk associated 

with vaccination. Investigation does not always confirm multiple cases at the same facility. They 

certainly have heard of some cases that have been ruled out at the same facility. True clustering 

of anaphylaxis would be concerning, but is very unlikely. There is no indication of clustering, 

even if there are 2 cases.

Ms. McNally indicated that she is the consumer representative on the ACIP. Because it is a new 

system, she asked whether V-SAFE is performing as anticipated.

Dr. Clark said that while he was not sure how everyone anticipated it would perform, they have 

been very pleased with how it is performing in terms of the number of persons enrolled and in 

the events being reported. He did a quick calculation and determined that the number of 

enrollees was approximately two-thirds of the number of doses administered around the same 

time. Therefore, uptake seems good. There have been minor tweaks to the system, but overall it

is performing well and allows CDC to trigger further investigation within the system and with inperson phone follow-up.

Use of mRNA COVID-19 Vaccines: Interim Clinical Considerations

Sarah Mbaeyi, MD, MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Mbaeyi reviewed clinical considerations for the use of mRNA COVID-19 vaccines in the US. 

As a reminder, proposed clinical considerations for the use of Pfizer-BioNTech COVID-19 

vaccine were presented to ACIP on December 12, 2020 and the final considerations were 

published to the CDC website. These clinical considerations will be updated to include 

information on both authorized mRNA vaccine products, Pfizer-BioNTech and Moderna COVID19 vaccines. The guidance has been harmonized across products with few differences, 

including differing age indications and dosing schedules. In this presentation, Dr. Mbaeyi 

focused on considerations around contraindications and precautions to vaccination.
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For both of the currently authorized mRNA COVID-19 vaccines, severe allergic reaction (e.g., 

anaphylaxis) to any component of the vaccine is a contraindication to vaccination listed in the 

prescribing information. The prescribing information also stipulates that appropriate medical 

treatment used to manage immediate allergic reactions must be immediately available in the 

event that an acute anaphylactic reaction occurs following administration of the vaccine. This 

table shows the ingredients included in the mRNA vaccines, as reported in the prescribing 

information:

Both vaccines consist of nucleoside-modified mRNA encoding the viral spike glycoprotein of 

SARS-CoV2. In addition, both contain 4 different lipids, some of which are common between the 

two vaccines, as well as salts, sugars, and buffering agents. Neither vaccine contains

preservatives or latex. Polyethylene glycol (PEG) is a component of both vaccines. PEG is a 

primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy procedures 

and is also found as an inactive ingredient or excipient in other medications and is used in a 

process called PEGylation to improve the therapeutic activity of some medications, including 

certain chemotherapeutics.

While the reports of anaphylaxis in persons who received the Pfizer-BioNTech COVID-19 

vaccine are further investigated, CDC considers a history of severe allergic reaction (e.g., 

anaphylaxis) to any other vaccine or injectable therapy (e.g., intramuscular, intravenous, or 

subcutaneous) as a precaution but not a contraindication to vaccination to both the PfizerBioNTech and Moderna COVID-19 vaccines as these vaccines contain some ingredients in 

common. A risk assessment should be conducted in persons who report history of severe 

allergic reaction, such as whether the reaction required use of epinephrine or resulted in 

hospitalization. These persons may still receive vaccination, but they should be counseled about 

the unknown risks of developing a severe allergic reaction and balance these risks against the 

benefits of vaccination.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Persons with a history of other types of allergies do not have a contraindication or precaution to 

vaccination, such as those with:

 History of food, pet, insect, venom, environmental, latex, or other allergies not related to 

vaccines or injectable therapies

 History of allergy to oral medications (including the oral equivalent of an injectable 

medication)

 Non-serious allergy to vaccines or other injectables (as in did not have anaphylaxis)

 Family history of anaphylaxis but no personal history

 Or any other history of anaphylaxis that is not related to a vaccine or injectable therapy

CDC recommends that vaccine providers observe all persons after vaccination. Those with a 

history of anaphylaxis due to any cause should be observed for 30 minutes. All other persons 

should be observed for at least 15 minutes after vaccination to monitor for the occurrence of 

immediate adverse reactions. This figure is included in the clinical considerations document and 

is intended to assist vaccine providers to better determine which patients may proceed with 

vaccination, which have precautions to vaccination, and which have contraindications to 

vaccination:

The figure includes information on how to approach patients with medical conditions, as well as 

a history of allergic reactions. In green are patients with a history of allergies in whom there is 

no precaution or contraindication to vaccination. As mentioned earlier, those with a history of 

anaphylaxis should be observed for 30 minutes, whereas all other persons should be observed 

for 15 minutes. In the next column in yellow are persons with a history of anaphylaxis to another 

vaccine or an injectable therapy. A risk assessment should be conducted in these patients and if 

vaccinated, they should be observed for 30 minutes. In red are patients with a history of severe 

allergic reaction to any component of the Pfizer-BioNTech COVID-19 vaccine. These people 

should not be vaccinated.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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In addition, CDC has developed tools that providers can use at the vaccination site to help 

identify persons with contraindications or precautions to vaccination, including a pre-vaccination 

form and further additional information in a fact sheet. CDC also has developed interim 

considerations for preparing for the potential management of anaphylaxis at COVID-19 

vaccination sites. These considerations include information on early recognition of anaphylaxis, 

medications and supplies needed for the assessment and management of anaphylaxis, how to 

manage anaphylaxis at the vaccination site, patient counseling, and reporting of anaphylaxis. 

Fact sheets are under development, including one tailored to LTCFs, given some unique 

challenges that may be encountered, such as recognizing anaphylaxis in persons with impaired 

cognition or who cannot communicate symptoms following vaccination. The key take-home 

messages from CDC’s anaphylaxis guidance include early recognition of anaphylaxis

symptoms, prompt treatment with epinephrine, and immediate activation of emergency medical 

services.

COVID-19 vaccines likely will be administered in a wide variety of clinical settings, including 

hospitals, LTCFs, outpatient medical offices, pharmacies, mass vaccination sites, and curbside 

or drive-through sites. These settings differ in terms of usual on-hand human and material 

resources to manage anaphylaxis. CDC’s guidance includes a list of medications and supplies 

that are important for evaluating and managing anaphylaxis and are recommended for COVID19 vaccination sites. These are divided into supplies/medications that should be available at all 

sites as the minimum requirements to assess and manage anaphylaxis, as well as other 

medications/supplies that are helpful to include where feasible:

In closing, Dr. Mbaeyi posed the following questions for ACIP discussion: 1) Does ACIP agree 

with the proposed contraindications and precautions to vaccination?; and 2) Are there any other 

sections of the clinical considerations that ACIP would like to discuss?
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Discussion Points

Dr. Talbot indicated that she likes and appreciates the layout. The only thing she found to be 

missing was a brief description of anaphylaxis and the different types of anaphylaxis. She thinks 

there is a misconception in the community and the healthcare field that there must be wheezing 

for anaphylaxis to be occurring, which is not the case. Therefore, a description of how 

anaphylaxis presents should be included so that everyone can recognize it.

Dr. Mbaeyi indicated that the guidance and fact sheets include some of the characteristics of the 

signs and symptoms of anaphylaxis to help make that information accessible and 

understandable to all types of providers.

Ms. Stinchfield (NAPNAP) asked what considerations and advice are included for repeat doses 

at the time of vaccination if there is a malfunction with the needle and some of the dose is lost.

Dr. Mbaeyi indicated that the general advice is that if there is an issue with administration of the 

vaccine in which someone did not receive a dose, the person is considered not to have received 

a vaccine. If someone received a partial vaccine, additional dosing is not recommended at this 

time.

Dr. Hunter strongly supported this very helpful information and commented that this is just 

another example of how everyone at CDC cares about patients, people, and populations and 

converting scientific information into showing that they care by making it detailed enough to be 

useable by clinicians and public health practitioners. He looks forward to helping disseminate 

this information in the community.

Dr. Fryhofer (AMA) found this to be a fabulous presentation that is so helpful to clinicians. She is 

very encouraged that so many people have signed up for V-Safe. Though there are media 

reports that cyber-attacks could somehow make that information less clear, she hopes that will 

not happen. She greatly appreciated the comments from members of ACIP, particularly the 

comment to actually describe what anaphylaxis is so that everyone is on the same page. 

Regarding Slide 6, she thought it was fabulous that CDC clearly listed the ingredients in these 2

vaccines. She noted that in Moderna’s presentation, they said that their LNP is comprised of 4 

different lipids, one of which is proprietary. She assumed that to be SM-102. Pfizer is very 

transparent as to the ingredients. She encouraged Moderna to do the same. People who have 

allergic reactions sometimes know what they are allergic to. The amount does not have to be 

given, but providing patients with a little more information as to what the secret is might be 

important, because it is essential to determine what might be triggering these anaphylactic 

reactions. That is definitely going to affect vaccine implementation.

Dr. Bell stressed that the evidence of the work that has been done about clinical considerations 

shows how the system is working. She also emphasized the importance of thinking of these as 

interim clinical considerations. While the instructions for anaphylaxis may work well in the 

current vaccination settings, this will need to be evaluated when there is more information and 

when vaccinations are being administered in other settings where the general calculus may 

differ.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

38

Dr. Sanchez suggested that some mention should be made in the algorithm for triage of 

persons with precautions and indications in terms of subsequent doses. If someone has had a 

reaction that is not considered anaphylactic, there still needs to be discussion about individuals 

who experience some reaction and whether there should be additional monitoring for 

subsequent doses.

Dr. Bernstein said he was not aware how often there is PEG associated anaphylaxis with bowel 

preparation for colonoscopy and wondered whether information about that would be helpful to 

adult clinicians. In addition, he thought it would be valuable to include the concept about the 

number of doses that can be obtained from a particular vial since there is no preservative in the 

COVID-19 vaccines. With the multi-dose Fluzone® only 10 doses are to be removed and the 

rest is supposed to be discarded. An explanation regarding squeezing out extra doses of 

COVID-19 vaccine would be helpful in the clinical considerations. He also wondered if there is a 

requirement to offer information about V-SAFE at places where the vaccine is distributed. He is 

aware of a couple of states that received the vaccine but V-SAFE was not even mentioned. A lot 

of people are likely to take a “wait and see” perspective, so the more information that V-SAFE 

provides, the better.

Dr. Mbaeyi said that based on the literature, it appears to be relatively uncommon, but there has 

been speculation that perhaps it is under-recognized. While difficult to quantify, it is generally 

thought to be somewhat rare. 

Dr. Messonnier said that CDC recognizes the importance of the topic of extra doses and agrees 

with the framing that in this time of public health crisis, no one wants to squander a single dose 

of a vaccine that is potentially life-saving. There is a plan to have a short discussion on the 

second day of the meeting, recognizing that information is important to incorporate into the 

clinical guidance. In terms of V-SAFE, she expressed hope that those listening are working to 

ensure that their administration sites are providing information about V-SAFE. There also is 

information on the CDC website. CDC’s perception based on the number of people who have 

enrolled in V-SAFE is that the message is getting out to many places, but even one site not 

having this information is something they want to correct. Given how complicated this has been, 

she offered a large shout out to the large number of people in jurisdictions who have been 

helping to get this program launched during the first week of vaccine distribution. It has been 

incredibly gratifying to see how smoothly this has gone despite some challenges. CDC will 

continue to work to correct it. 

Ms. Bahta said that in the field, they are hearing of difficulty getting doses of epinephrine in the 

vial or autoinjector presentations and wondered what CDC knows about this. She also 

expressed concern about some newer vaccinators and their potential lack of consideration for 

having epinephrine on hand. Perhaps some guidance should be included about this and about 

whether to hold clinics without epinephrine.

Dr. Mbaeyi indicated that CDC would get back to ACIP with some additional information on the 

issues pertaining to epinephrine.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Motion/Vote: Moderna COVID-19 Vaccine

Ms. Bahta made a motion that ACIP recommend the Moderna COVID-19 vaccine for persons 

18 years of age and older under the FDA’s Emergency Use Authorization (EUA). Dr. Szilagyi 

seconded the motion. Drs. Atmar, Frey, and Hunter recused themselves from the discussion, 

motion, and vote due to their previously stated COIs. The motion carried with 11 affirmative 

votes, 0 negative votes, and 3 abstentions. The disposition of the vote was as follows:

11 Favored: Ault, Bahta, Bell, Bernstein, Lee, McNally, Poehling, Romero, Sanchez, 

Szilagyi, Talbot

 0 Opposed: N/A

 3 Abstained: Atmar, Frey, Hunter

Dr. Romero called upon ACIP members interested in sharing their thoughts about why they 

voted as they did to make comments.

Ms. Bahta said that she was very eager to support this vote for a second vaccine that could be 

lifesaving, especially in light of the fact that there are 2600 deaths per day on average. This is 

horrendous and she hopes that this can be reduced greatly, despite the fact that there is still 

much to learn about the disease and the vaccine.

Dr. Talbot expressed gratitude to the CDC and the FDA. This has been a momentous amount of 

work with very little credit given to them, and she appreciates every moment of it. These 

vaccines are going to change everything and she is very thankful.

Dr. Szilagyi emphasized that he voted for the vaccine because in his opinion, given the 

pandemic, the benefits far, far outweigh any risks. He emphasized that the ACIP’s process has 

been rigorous, fair, and transparent. He is very impressed with CDC’s safety monitoring system 

that is being rolled out. He thought the discussion about V-SAFE and the rapid guidance that 

CDC has prepared demonstrate the importance and value of the safety monitoring systems. He 

is confident that the ACIP’s recommendation is important and will bring the coronavirus 

pandemic to an end.

Dr. Bell said that to her, this is another step forward. There is still a lot to learn and there are 

likely going to be many bumps in the road, but ACIP has used a process that is science-based, 

fair, and transparent. All systems so far appear to be doing what they are supposed to do. This 

represents progress toward ending this horrific pandemic. She thanked all of the people who 

have come forward to be vaccinated and expressed her hope that continuing to share 

information as they learn it will make people feel more comfortable with the risk/benefit before 

them.

Dr. Lee emphasized that she voted “yes” for the interim recommendation under the EUA 

because of the incredible need for additional vaccine doses to be able to protect individuals and 

communities. She also called out that the implementation considerations for this vaccine mean 

that it will be possible to extend use into communities that have been more difficult to reach with 

the currently available Pfizer vaccine. Both vaccines are outstanding in terms of benefit/risk 

balance, but she does think additional options will need to be available to ensure that as much 

of the population as possible is captured and covered.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

40

Dr. Romero reiterated to the public that safety has been a paramount focus of the CDC, ACIP, 

FDA, VRBPAC, and the pharmaceutical industry. These vaccines were found to be safe in 

clinical trials and safety nets are now identifying unusual events. The public needs to 

understand that safety has been stressed throughout the entire process. The inclusion of 

minority groups and persons of color by the pharmaceutical industry is extremely important. 

Concern has been expressed that there would not be a sufficient number of persons of color. As 

a person of color, Dr. Romero said he feels that this has been and will continue to be properly 

addressed going forward. He thanked all of the voting members who have spent so much time, 

including weekends, this year to come to these votes; the liaison members who have actively 

contributed throughout the entire process; and the CDC staff and leaders for all that they have 

done.

Dr. Cohn expressed CDC’s gratitude to Dr. Romero as Chair and all of the 14 voting ACIP 

members that CDC is incredibly grateful for the amount of thought, input, and expertise they all 

have provided to this effort—especially in terms of spending the entire weekend with them 

before the holidays to ensure that they can get these vaccines out to the American people.

Call to Order / Roll Call / Announcements

José Romero, MD, FAAP

ACIP Chair

Amanda Cohn, MD

Executive Secretary, ACIP / CDC

Dr. Romero called to order the second day of the December 19-20, 2020 emergency meeting of 

the Advisory Committee on Immunization Practices (ACIP). He indicated that the purpose of the 

December 20, 2020 session was to discuss and vote on allocation of the Moderna Coronavirus 

Disease 2019 (COVID)-19 vaccine for Phases 1b and 1c. He conducted a roll call of ACIP 

voting members. The following COIs were declared during the first day of the meeting and were 

determined during this roll not to be relevant to the discussion, motion, or vote on Phases 1b 

and 1c allocation of vaccine supplies. Drs. Atmar, Frey, and Hunter were permitted to 

participate.

 Dr. Robert Atmar is serving as the Co-Director of the Clinical Operations Unit (COU) of the 

National Institutes of Health (NIH)-funded Infectious Diseases Clinical Research Consortium

(IDCRC) that is working within the COVID-19 Prevention Network (CoVPN) to evaluate 

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) vaccine candidates in 

Phase 3 clinical trials. She is the Site Principal Investigator (PI), including those produced by 

Moderna, AstraZeneca, Janssen, Novavax, and Sanofi. 

 Dr. Sharon Frey is employed by Saint Louis University (SLU), which has a Vaccine 

Treatment Evaluation Unit (VTU) that is part of the IDCRC. She is currently serving as the 

Site PI for the Moderna and Janssen Phase III COVID-19 vaccine clinical trials. 

December 20, 2020: Opening Session 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

41

 Dr. Paul Hunter owns a small amount of stock in Pfizer and has received a small grant from

Pfizer to conduct a quality improvement (QI) project on pneumococcal vaccines.

Dr. Cohn encouraged everyone to review the public docket. The comments submitted are 

incredibly informative and demonstrate the huge amount of interest that everyone feels about 

these vaccines and set up the discussion for the day. These are available under Docket Number 

CDC-2020-0124 at https://www.regulations.gov.

The slides to be presented during this session were made accessible to the public via 

https://www.cdc.gov/vaccines/acip/meetings/slides-2020-12-19-20.html. 

Guidance on Vaccine Doses

Doran Fink, MD, PhD

Deputy Director-Clinical

Division of Vaccines and Related Products Applications

Center for Biologics Evaluation and Research 

Food and Drug Administration

Dr. Fink acknowledged that as most people have heard from the news, through discussions at 

ACIP, or from information provided by FDA Commissioner Hahn that the Pfizer CVOID-19 

vaccine was authorized for used based on an intended number of doses of 5 within the multidose vials. However, it turns out that more than 5 doses routinely can be obtained from the 5-

dose vials adhering to the dose preparation instructions outlined in the prescribing information 

and the fact sheet for healthcare providers (HCP). Based on the volume that is achieved on 

dilution of the vaccine that is provided in the vial, typically 6 doses are obtainable. Sometimes 

with very skilled preparation, a 7th dose might be obtained as well. FDA has posted on its 

website, in the context of a Frequently Asked Question (FAQ) on the page for the Pfizer 

vaccine, advice that FDA is aware of this issue. FDA is working with Pfizer to update the 

prescribing information and fact sheets for HCP to reflect what is considered to be instructions 

for optimal use of the vaccine to address the pandemic by using every full dose that can be 

obtained from each vial while adhering to the instructions for dose preparation. This usually will 

result in 6 and possible 7 doses. FDA wants to make sure that HCP are aware that the vaccine 

is preservative-free and that any product left in a vial that is not enough to make a full dose 

should not be used or pooled with vaccine from other vials. In order to address the pandemic, 

FDA wants HCP to use every full dose that can be obtained from each vial while adhering to the 

instructions for preparation.

Vaccine Availability

Nancy Messonnier, MD

Director 

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Messonnier provided an update on the amount of vaccine anticipated to be available over 

the next couple of months. She emphasized that CDC’s goal remains to have enough vaccine 

and the ability in the vaccine program to vaccinate everybody in every corner of every one of the 

US’s communities as possible. However, there will be a limited supply of vaccine at least in the 

short-term. What that means is that there will be difficult choices about who gets that vaccine 

first. This is just one of the many difficult choices that society has faced this year. The goal of 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

42

the ACIP is to provide guidance for vaccine prioritization, with the understanding that such 

guidance will then need to be translated to a local context. To provide some framing around how 

much vaccine CDC anticipates being available, she shared some estimates as described by 

Secretary Azar earlier in the week that there should be enough vaccine to vaccinate 20 million 

people in December, 30 million people in January, and 50 million people in February. Dr. 

Messonnier emphasized that these are projections based on the current understanding of 

vaccine availability. Certainly, the hope is that more vaccine will be available. As is true with all 

vaccines, however, it is important to understand the possibility that there will be less vaccine.

Hopefully, these numbers will help ACIP with the difficult discussions to be had during this 

session. She thanked the ACIP members for their difficult deliberations as they have thought 

about prioritization and anticipating this moment since beginning discussions pertaining to 

COVID vaccines. She said she knew as always that ACIP would think about the science framed 

around ethics and the need to be practical in terms of implementation.

Introduction

Beth Bell, MD, MPH 

ACIP, COVID-19 Vaccine WG Chair

Clinical Professor, Department of Global Health

School of Public Health, University of Washington 

Dr. Bell introduced the session, reminding everyone that the agenda for the day would include 

presentations on the following topics: 

December 20, 2020

 Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b and 1c

 Considerations for Populations Included in Phases 1b and 1c

 Public Comment Prior to the Vote

 Vote on Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b and 1c

Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b and 1c

Kathleen Dooling, MD MPH

Co-Lead ACIP COVID-19 Vaccine WG

Medical Officer, National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling presented on phased allocation of COVID-19 vaccines on behalf of the ACIP 

COVID-19 WG. The policy question under consideration is, “Which groups should be offered 

COVID-19 vaccination in Phase 1b & 1c?” Dr. Dooling began by reviewing the goals of the 

COVID-19 Vaccine Program that have been guiding the ACIP COVID-19 WG discussions, 

which are to: 1) ensure safety and effectiveness of COVID-19 vaccines; 2) reduce transmission, 

morbidity, and mortality of COVID-19 disease; 3) help minimize disruption to society and the 

economy, including maintaining healthcare capacity; and 4) ensure equity in vaccine allocation 

and distribution.

Allocation of Initial Supplies of COVID-19 Vaccines: Phases 1b & 1c
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Anticipating that demand for COVID-19 vaccine will exceed supply for the first months of a 

national vaccination program, the WG has endeavored to balance the goals of prevention of 

morbidity and mortality along with the preservation of societal functioning, including maintaining 

healthcare capacity. In this setting, difficult choices have to be made and the WG has learned,

listened, and debated how to achieve that balance. Members of the WG strongly support 

vaccination being offered to every person in the US as soon as possible. The following 

presentation offers a roadmap for how to get there together.

In efforts to achieve the goals of the program, on December 1, 2020 ACIP recommended that 

residents of long-term care facilities (LTCF) as well as healthcare personnel (HCP) be offered 

vaccination first in Phase 1a. In deliberation of those recommendations and for the remaining 

vaccine allocation, ACIP has held 10 public ACIP meetings and there have been 28 COVID-19 

WG meetings. The WG has examined a broad range of evidence from scientific,

implementation, and ethical fields. The WG also considered external expert advice from the 

National Academies of Science, Engineering, and Medicine (NASEM) who provided a timely 

framework for the equitable allocation of COVID-19 vaccine to inform ACIP and CDC. The WG 

also took into account academic reports and allocation recommendations from other countries 

and organizations. Importantly, the WG deliberations have been informed by public input. These 

have come in the form of focus groups involving hundreds of people, population surveys,

previous work on pandemic preparedness, and of course ACIP public comment and Federal 

Registry submissions. These inputs have informed the WG’s understanding of public values and 

have helped shape the evolution of the proposed phased allocation.

As mentioned, residents of LTCF as well as HCP will be offered vaccination first in Phase 1a. 

The WG proposes that in Phase 1b, person 75 years and older and frontline essential workers 

be offered COVID-19 vaccination. All persons 65 to 74 years of age, persons 16 to 64 years of 

age with high-risk medical conditions, and all other essential workers not previously 

recommended should be offered vaccines in Phase 1c. Essential workers have been 

categorized by the WG group as either “frontline” or “other” essential workers. The WG 

categorization of frontline workers was informed by the NASEM. Their framework for equitable 

allocation of vaccine indicates that in the first 2 phases the following workers should be offered 

vaccination first: first responders, teachers, school staff, childcare workers, critical workers in 

high-risk settings, and staff working in congregate settings.

Similarly, the ACIP WG has defined frontline essential workers as “workers who are in sectors 

essential to the functioning of society and are at substantially higher risk of exposure to SARSCoV-2,” the virus that causes COVID-19 disease. Specifically, these include first responders

(firefighters and police); people in the education sectors (teachers, support staff, daycare 

workers); and those who work in food and agriculture, manufacturing sectors, corrections 

workers, US Postal Service workers, public transit workers, and grocery store workers. Other 

essential workers include those who work in transportation and logistics, food service, shelter & 

housing (construction), finance, information technology (IT) & communication, energy, media, 

legal, public safety (engineers), and water & wastewater. The description of all essential 

workers can be found at the Cybersecurity and Infrastructure Security Agency (CISA) website.

To put that all together, here are the proposed phases for COVID-19 vaccination as well as their 

intersections:
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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The large square is the US population 16 and older separated out by people 75+, 65 to 74, and 

16 to 64 with and without high-risk medical conditions. In the light blue are Phase 1a, HCP and 

LTCF residents. In the slightly darker blue are the proposed Phase 1b frontline essential 

workers and persons 75 and older. In the darkest blue are the groups proposed for Phase 1c,

persons 65 to 74, essential workers not previously recommended, and persons 16 to 64 with 

high-risk medical condition.

Proceeding to the highlights of the evidence that the WG considered, to examine the policy 

question of which group should be recommended to receive COVID-19 vaccines in Phases 1b

and 1c, the WG considered information in the 3 pillars of science, implementation, and ethics. In 

terms of the science pertaining to the epidemiology of COVID-19 disease burden and the 

potential impact of vaccine, national estimates of COVID-19 confirmed cases by age group 

show that COVID-19 incidence is highest among young adults. On the other hand, COVID-19 

mortality rates are highest in older adults. The national estimates of death per 100,000 

population rises steeply after age 65. Death from all causes increases with age. However, the 

proportion of deaths associated with COVID-19 is actually similar across middle-aged and older 

adults.

Over the course of this year, adults 75 years and older have accounted for 25% of COVID-19-

associated hospitalizations despite making up approximately 8% of the population. In terms of 

hospitalization trends over time, the rates for 75 to 84 years of age and 85 years of age and 

older in particular have risen sharply over the past couple of months far exceeding those of 

younger adults. A published paper featuring COVID-Net data shows that compared to people 

without underlying medical conditions, adults with one or more conditions were significantly 

more likely to be hospitalized for COVID-19. That risk increased if a person had multiple 

conditions. Older adults living in the community also were more likely to be hospitalized for 

COVID compared to younger adults. However, in this adjusted analysis, the magnitude of the 

association was smaller compared to having comorbidities. It should be noted that persons 

living in LTCF were excluded from the analysis [Ko, Sept 2020, doi: 10.1093/cid/ciaa1419]. In 

contrast, among persons hospitalized for COVID-19, another paper showed that risk of inhospital death increased dramatically with age with adjusted rate ratios ranging from 6 to 11 in 

age groups 65 and older.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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Shifting the focus to essential workers, a manuscript in preparation by Sami et al shows high

seroprevalence among many frontline essential worker groups following the first wave of 

pandemic in New York City (NYC). Since these data reflect exposures that occurred before July

2020, it is unknown to what extent these workers are still protected. To illustrate the age 

distribution of essential workers and the intersection between the proposed groups, data from 

the American Community Survey (ACS) 2019 and the 2019 Behavioral Risk Factor Surveillance 

System (BRFSS) show that while approximately half of essential workers are older than 40 

years old, 8% to 11% are actually older than 65. Also, it is known that among adults 18 to 64

years of age, 56% have a medical condition or behavioral risk factor that is associated with 

increased risk of severe COVID.

To summarize the modeling work that was done and previously presented to the ACIP, in the 

scenarios that were considered, differences between strategies is minimal. Vaccinating older 

adults first averts slightly more deaths, while vaccinating younger adults first (essential workers 

and younger adults with high-risk conditions) averts slightly more infection. The WG concluded 

that ethical principles and implementation considerations also should contribute to the optimal 

sequence in Phase 1b and 1c. The largest driver of impact for averting deaths and infections is 

actually the timing of the vaccine introduction related to increases in COVID-19 cases. This 

really emphasizes the need to continue non-pharmaceutical interventions such as wearing a 

mask and social distancing to prevent cases so that the vaccine can have its maximum impact. 

The vaccine’s ability to prevent transmission will further inform modeling analysis and 

interpretation. As seen in the previous day’s presentation on the Moderna vaccine, preliminary 

data indicate that the vaccine may reduce transmission; however, more study is needed to be 

certain.

There are many impacts of COVID-19 that were not included in modeling because there simply

is not enough known yet about this disease to include them. One major issue is late sequelae of 

COVID-19, colloquially referred to as “long-haul COVID.” Some of the more commonly longlasting symptoms include fatigue, dyspnea or shortness of breath, cough, arthralgia, and chest 

pain. More serious complications appear to be less common, but long lasting medical problems 

may result, such as myocardial inflammation, ventricular dysfunction, lost pulmonary function,

acute kidney injury, rash, alopecia, olfactory and gustatory dysfunction, sleep dysregulation, 

altered cognition, memory impairment, depression, anxiety, and/or changes in mood. Ultimately,

even COVID-19 cases that may not result in hospitalization or death can still have important 

health consequences and need to be prevented.

Turning to implementation, the WG proposed guiding principles in June 2020 of which 2 pertain 

to implementation: efficient distribution and flexibility. During a pandemic, efficient, expeditious 

and equitable distribution of, and administration of authorized vaccines is critical. With respect to 

flexibility, within national guidelines, state and local jurisdictions should have flexibility to 

administer vaccine based on local epidemiology and demand. Dr. Dooling indicated that Dr. 

Sara Oliver would speak to the details of operationalizing these principles in the next 

presentation.

When considering feasibility of vaccinating adults 65 and older, a potential challenge early in the 

program is potentially the long distances needed to drive to central clinics and the high 

throughput needed for these clinics. On the positive side, older adults report high intent to 

receive COVID-19 vaccine. There is a wide network of physician offices, pharmacies, and public 

health clinics that are established providers of adult vaccination. Surveys indicate that 73% to 

82% of respondents supported priority vaccination of persons 65 and older [

1, 2

AP-NORC Center 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

46

for Public Affairs Research. Many remain doubtful about getting COVID-19 vaccine. December 

2020. https://apnorc.org/projects/many-remain-doubtful-about-getting-covid-19-vaccine. 3

ABC/

IPSOS poll. December 14, 20202,3. https://www.ipsos.com/en-us/news-polls/abc-newscoronavirus-poll].

When considering the implementation of COVID-19 vaccination for essential workers, a 

potential challenge is reaching workers in rural locations, shift workers, and those working 

multiple jobs or working in small cohorts. To overcome this, jurisdictions are working on 

solutions such as on-site occupational clinics, pharmacies, or a health department point-ofdispensing (POD) strike team. Surveys indicate that 68% to 87% of respondents supported 

priority vaccination of essential workers such as police, fire, rescue, and teachers. For adults 

with medical conditions that put them at increased risk of severe COVID, a potential challenge is 

determining eligibility in this very large group. Again, there is the benefit of a wide vaccination 

provider network and healthcare homes such as physician offices or pharmacies could be better 

suited to verify underlying medical conditions. Surveys indicate that 68% to 84% of respondents 

supported priority vaccination of persons who are at high risk because of medical problems [1. 

The Harris Poll: https://www.axios.com/who-gets-coronavirus-vaccine-first-4ff87ff8-39d7-49d6-

8d25-fa2307119235.html.  2. AP-NORC Center for Public Affairs Research. Many remain 

hesitant about getting COVID-19 vaccine. December 2020. https://apnorc.org/projects/manyremain-doubtful-about-getting-covid-19-vaccine. 3. ABC/IPSOS poll. December 14, 

2020. https://www.ipsos.com/en-us/news-polls/abc-news-coronavirus-poll].

Now to consider ethics. Vaccinating older adults maximizes benefits and minimizes harms by 

reducing directly the morbidity and mortality in persons with higher burden of COVID-19 

hospitalizations and death. Promotion of justice while vaccinating this group will require focused 

outreach to those who experience barriers to accessing healthcare. It also was noted that 

persons living in multi-generational households may be at greater risk of exposure. With respect 

to mitigating health inequities, racial and ethnic minority groups are under-represented among 

older adults. However, minorities within this group have experienced disproportionate COVID19-related hospitalizations and deaths.

Essential workers are at high risk because of exposure by virtue of being in contact with others 

in performing their duties. Prevention of disease in essential workers may reduce transmission 

to others. This preserves work essential to the COVID-19 response and overall functioning of 

society, which is referred to as the “multiplier effect.” In terms of promoting justice, it was noted 

that frontline workers in particular are unable to work from home and have a high level of 

interaction with the public or others in the workplace. In fact, in some instances, they may not be 

able to control social distancing. This approach mitigates health inequities as racial and ethnic 

minorities groups are disproportionately represented in many essential industries, and 

approximately one-quarter of essential workers live in low-income families.

Vaccinating persons 16 to 64 years of age reduces morbidity and mortality in persons with 

moderate to high burden of COVID-19-associated hospitalization and death. Focused outreach 

to those with limited or no access to healthcare will be needed to promote justice in a rollout. In 

terms of mitigation of health inequities, while there is an increased prevalence of some medical 

conditions in racial or ethnic minority groups and persons in rural areas, diagnosis of these 

conditions may require access to healthcare.
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47

In summary of the WG’s considerations, scientific, implementation, and ethical considerations 

support inclusion of groups in Phase 1b and 1c as a balance of prevention of morbidity and 

mortality and preservation of societal functions. This represents an interim Phase 1 sequence. 

Allocation policy will need to be dynamic and adapt as new information becomes clear, such as 

vaccine performance and supply and demand. Gating criteria will be necessary to move 

expeditiously from one phase to the next, if supply exceeds demand. Following vaccination, 

measures to stop the possible spread of SARS-CoV-2, such as masks and social distancing, 

will still be needed. The US Government (USG) is committed to making COVID-19 vaccines 

available to all residents as soon as possible.

For the proposed Phase 1 and 2 allocation, Phase 1b includes frontline essential workers and 

persons 75 and older for a total of approximately 49 million unique persons. Phase 1c 

comprises persons age 65 to 74 years old, persons age 16 to 64 years with high-risk medical 

conditions, and essential workers not recommended in Phase 1b. Once overlap among the 

groups is accounted for, this will include approximately 129 million unique persons. Phase 2 

consists of all peoples 16 years and older who were not recommended in Phase 1. Given the 

size of the proposed groups, this is an example of Phase 1 and Phase 2 COVID-19 vaccine rollout over time:

The following is the proposed interim recommendation:

As an update to ACIP recommendations for vaccination in Phase 1a (health care 

personnel and long-term care facility residents) if COVID-19 vaccine supply is limited, 

the following groups should be offered vaccination:

Phase 1b: persons ≥75 years and older and frontline essential workers

Phase 1c: persons aged 65 to 74 years, persons aged 16 to 64 years with high-risk 

medical conditions, and other essential workers
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48

Considerations for Populations Included in Phases 1b and 1c

Sara Oliver MD, MSPH 

Co-Lead ACIP COVID-19 Vaccine WG

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Oliver briefly covered considerations for Phases 1b and 1c, including transitioning between 

phases, sub-prioritization considerations, and other considerations for populations in Phases 1b

and 1C.

A strategy for transitioning between phases will be necessary to move to the next phase as 

supply increases and may exceed demand for the current phase. However, vaccination within 

the phases may, and likely will, overlap. It is not necessary to fully complete vaccination in one 

phase before moving to the next phase. Decisions on moving to the next phase will be made 

and detailed at a state or local level. There are suggested strategies for this transition between 

phases. When demand in the current phase is less than the vaccination capacity, this can be 

determined using local metrics. An example would be if appointments to be vaccinated are less 

than 80% filled for several days. Another reason to move into the next phase would be if supply 

increases significantly either due to more doses available of the current vaccine or if a new 

vaccine is authorized. Finally, considerations to move into the next phase would include if or 

when most persons within the current phase are vaccinated. This will obviously depend on 

vaccine uptake within various populations and will be informed based on the state and local 

situation.

As has been done for HCP and LTCFs, the WG wanted to provide some consideration for subprioritization. The goal is for all frontline workers to receive the vaccine. However, where subprioritization of these frontline workers is needed due to limited vaccine supply initially, 

jurisdictions could consider workers in locations where high rates of transmission and/or 

outbreaks have occurred and also workers who are at increased risk for severe illness based on 

age or underlying medical conditions. However, a worker’s privacy should be considered with 

the situation. Some workers may not want to disclose a full medical history to an employer. 

Because of that, using self-identified medical condition status may be best. As was done for 

HCP, considerations also could include workers who do not have a history of documented acute

SARS-CoV-2 infection in the prior 90 days. The goal is for the COVID vaccination program to 

extend to every corner of every community in the US so that everyone has the opportunity to 

receive a COVID vaccine. However, during this brief time period of constrained supply, state 

and local jurisdictions may have to make decisions around how the initial supplies of COVID 

vaccine will be distributed. The MMWR describing the ethical principles used as a component 

for these decisions includes a table with very practical questions that state and local jurisdictions 

can use to make decisions around this planning.

For other considerations for Phases 1b and 1c, mRNA vaccines are currently not recommended 

for outbreak management or for post-exposure prophylaxis (PEP), which is vaccination to 

prevent the development of SARS-CoV-2 infection in a person with a specific known exposure.

Both available mRNA vaccines are a 2-dose series. Protection from these vaccines is not 

immediate. It takes 1 to 2 weeks following the second dose before a person is considered fully 

vaccinated. With a median incubation period of 4 to 5 days, it is unlikely that vaccination would 

prevent disease from a singular specific exposure. However, based on local epidemiology and 

implementation considerations, jurisdictions may choose to vaccinate frontline essential workers 

and persons who reside at congregate living facilities, such as prisons, jails, or homeless
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49

shelters at the same time. The epidemiology of COVID-19 is constantly evolving. Knowledge of 

the currently available vaccines will increase. Additional vaccine may be authorized, or 

authorization may expand to other populations or ages over time. These considerations and 

additional guidance for Phases 1b and 1c and Phase 2 will be updated as more is known about 

COVID-19 epidemiology and vaccines.

Discussion Points

Dr. Romero noted that over the last two months, there has been introduction of monoclonal 

antibodies that are designed to be used in an outpatient setting and may impact hospitalization 

and mortality. He wondered if those were factored into this in any way and/or whether they 

would have an impact on the projections over time.

Dr. Dooling indicated that the WG did not specifically consider the use of monoclonal antibodies 

either as an adjunct or another strategy for the prevention of COVID.

Dr. Bell added that the WG has not yet considered monoclonal antibodies and given the extent 

of use of monoclonal antibodies right now, it is not likely to have an impact for the moment. It is 

another factor that the WG will need to consider and monitor over time as one of the many 

considerations that might change over time that could affect how the WG assesses allocation in 

the future.

Dr. Szilagyi agreed with this modification of the WG’s prioritization and thought it more clearly

aligned with the NASEM framework. He liked the concept of self-prioritizing with essential 

workers to frontline and other essential workers. Los Angeles County has been working very 

diligently on allocating and deciding what to do with the 10.5 million residents. There has been a 

lot of interest there in sub-prioritizing essential workers. This issue of the frontline workers goes 

very much along with what the county would want. He has also been worried about individuals 

75 years of age and older. One of the reasons he was favoring essential workers is because of

the disproportionate number of individuals who are minorities in the overall group of essential 

workers. He assumed the same would be true in terms of a disproportionate number of minority 

individuals among frontline essential workers, but wondered whether there were any data about 

that. He agreed with the concept of some flexibility within local regions and counties. As part of 

flexibility, he emphasized that at-risk individuals who live in very vulnerable, primarily low 

income communities need special outreach and additional efforts to reach those individuals 

because of the access barriers to vaccination.

Dr. Dooling indicated that there are data about this from the ACS. Frontline essential workers 

more closely model the racial makeup of the total US population, while there is a

disproportionate representation of minorities among the other essential workers.

Dr. Hunter very strongly agreed with the specifics of how the policy question was written. He 

thought there was enough specificity, along with general principles, such that states and local 

health departments could use both the specifics and the principles to further define this for their 

states. Those principles and specifics can even be used by employers and employee groups to 

come up with specifics of how vaccine should be implemented in their area. He thought there 

was a good balance between what the traditional role has been of federal public health 

guidelines that state and local jurisdictions implement. In terms of the algorithm, he noted that 

the three criteria he is used to working with are age, a supervisor’s description of the 

employee’s job duties, and CDC’s Social Vulnerability Index (SVI), which he assumed would 

map the employee’s residence onto the Census tract and based on the 15 criteria developed on 
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50

that. He wondered if anything was missing from that. He expressed appreciation for how much 

CDC cares about them in the real world and the people they serve.

Dr. Dooling indicated that the 3 elements are all things that the WG has spoken about and can 

be found in different ways in the clinical considerations that will accompany the 

recommendation. All are important and can be used in sub-prioritization. In terms of whether 

anything was missing, the flexibility to implement in every location would be a little bit different.

As mentioned, there will be a lot more detail coming in the clinical considerations document that 

will accompany the recommendation.

Dr. Duchin (NACCHO) emphasized the importance of program implementation, which is critical. 

ACIP’s recommendation the previous day for use of the second safe and effective COVID-19 

vaccine in as many weeks is another crucial milestone for eventually ending this terrible 

pandemic that continues to rule the country in so many ways. However, it is important to 

remember that a COVID-19 vaccination program is not just about vaccines, but about 

vaccination—getting those vaccines to the people who need them. At this point, state and local 

public health departments are on life support. They are hamstrung and stymied by the lack of 

necessary federal funding to allow them to take advantage of these newly available vaccines.

For example, resources are needed for public health vaccination clinics to ensure equitable 

access to vaccines across communities and populations, for coordination and enrollment of 

provisions and provision of support and technical assistance to healthcare providers around 

clinical guidance and vaccine allocation, and for the critical work of public engagement and 

communications. Operation Warp Speed (OWS) has delivered two “Cadillac” vaccines, but they 

have come with empty gas tanks. There is a long and difficult road ahead. There is a critical and 

immediate need for adequate funding and resources for vaccine program implementation so 

that as many people across the nation as possible are able to realize the full potential of these 

highly effective COVID-19 vaccines and realize the commitment they heard during the day that 

the federal government would make them available as quickly, efficiently, expeditiously, and 

equitably as possible.

Dr. Zahn (NACCHO) said the algorithm for Phases 1b and 1c made sense to him and he 

thought it would be very useful for local public health to prioritize who receives limited vaccines 

initially. He congratulated and expressed appreciation for all the work the WG and CDC have 

been doing. This framework will be very helpful as described to help local public health and local 

government and industry understand who is prioritized, but it also is going to be extremely 

important to make sure that the community individuals understand where they fit into it. It has to 

be translated to some relatively simple bullet points so that people can understand it and selfidentify so that they can understand exactly where they fit into it and seek vaccination. While 

everybody could guess, it is worth saying out loud that local public health has little enthusiasm 

for eventually being a traffic cop so to speak for every individual who may or may not get 

vaccinated. HCP likely feel the same way. There must be reliance on the people for appropriate

outreach. Focused outreach is public health’s job, particularly in terms of outreach to essential 

workers. This is a very important and noble goal, but it remains just a sentiment unless there is

federal funding to make that come alive—make that live and breathe on a local level. Federal 

funding is terribly important. It cannot be emphasized enough that preparations are weeks and 

months behind to really do this right.

Dr. Frey thanked Drs. Dooling and Oliver for excellent presentations, the WG, CDC, and 

everybody involved in this effort for the thoughtfulness and the amount of work that they have 

done on behalf of multiple communities within this country and others. Regarding the example 

of vaccinating correctional officers as essential workers and the residents of shelters, she 
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51

requested clarity on whether this meant the ability to vaccinate both groups at the same time as 

part of the Phase 1b effort, and how prioritization of the residents in 1c would occur since some 

people would be very elderly, some would have a certain amount of comorbidities, and all 

groups within the various facilities are very vulnerable for multiple reasons.

Dr. Oliver clarified that Dr. Frey interpreted the intent correctly. They wanted to emphasize that 

they were not recommending the mRNA vaccine as a tool for a singular point source outbreak, 

but instead it is based on local epidemiology at the local or states jurisdiction. There was a 

decision that based on outbreaks or rates of transmission broadly that the implementation and 

current status of disease would facilitate having broader access and vaccinating both prisoners 

and/or people residing in homeless shelters at the same time could be done. That absolutely

would be based on the local epidemiology and local decisions made.

Dr. Cohn added that this is the exact reason they want to have flexibility, so that no one has to 

split up residents in a homeless shelter into Phases 1b and 1c. Depending on how many doses 

are available, a choice could be made to vaccinate staff and also residents at the same time or,

if necessary, separate it out and vaccinate staff in 1b and older adults in 1b and then hold out 

the rest of the facility as 1c. This would give local jurisdictions the option to go either way 

depending on all of the different variables.

Dr. Sanchez found it difficult to choose because he certainly wants to vaccinate all Phase 1a, 

1b, and 1c as all of them are high risk. He also agreed that self-prioritization among essential 

workers and among those in 1c would be important depending on the vaccine supply. He was 

glad that this could be worked through at local and state levels, because some of the persons 

who are aged 65 to 74 years and those with high risk medical conditions are having to work in a 

crowded workplace compared to those who can work from home. Some of that thinking will 

need to be taken into consideration. The risk certainly would be less for someone who could 

work at home and quarantine as much as possible versus those who may not be essential but 

do have to go to the workplace. Some people over 65 years are retired. Those are going to be 

difficult to sort through. This is going to be a difficult process and everyone will need as much 

direction as possible. One thing is severity and the other is the exposure. Those with less 

exposure may not be relegated to the front of the line either.

Dr. Goldman (ACP) echoed what Dr. Duchin had so eloquently stated on implementation. 

Based on lessons learned from the initial phase and rollout, he pointed out that initial subprioritization can become a double-edged sword as a path of least resistance, making the 

allocation and equitable distribution even more inequitable as some localities are using it to 

vaccinate those using the easiest method possible but not necessarily those at highest risk. He 

stressed the importance of the frontline workers in outpatient medical centers and physician 

offices, including medical assistants, front desk, and clerical staff, who do not have access to

personal protective equipment (PPE) and are on the front lines being exposed to the patients. In 

many localities, there does not seem to be outreach, education, or the ability to get vaccines to 

those who need it the most. In addition to the importance of federal support and federal funding

is the importance of oversight. This remarkable feat of science has been created to get this 

vaccine out as quickly as possible, but it does not help if it does not get to the people it needs to 

get to as quickly as possible. There is concern that many localities are not truly following these 

guidelines in the way they were intended, to make sure that those most at risk and most 

vulnerable get the vaccines. That said, with this phased allocation, he applauded and stressed 

the work of the COVID-19 WG and thought it was a very balanced approach for Phase 1b and 

was the path for balancing the needs of society versus those most at risk for a bad outcome 

from disease. In summary, he stressed the importance of making sure these guidelines are 
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52

really looked at by localities so that the vaccine gets to where it is needed most and that those 

most at risk are not forgotten, especially the essential workers, the front desk workers, medical 

staff, medical clinics, and physician offices and the need to vaccinate everyone.

Mrs. McNally asked if the WG considered whether the clinical considerations would address 

both state and federal workers in the appropriate categories, such as the legal category in terms 

of the difference between state and federal court judges.

Dr. Dooling indicated that the CISA list of essential and critical infrastructure does not 

distinguish between state, federal, or local.

Dr. Lee acknowledged that this has been a complex set of discussions with multiple 

considerations. As mentioned earlier, she truly believes the goal is to make sure that everyone 

who wants a vaccine can get one. This is hopefully a path to get there that she hopes is a shortterm situation. Reflecting on the importance of the balance considerations for Phase 1b, she 

said she does feel that they are in a different place in the pandemic than a month or two ago

and she is very worried about health care capacity. In her mind, the approach of making sure 

that they are simultaneously considering risk of infection and risk of hospitalization and death in 

a balanced manner, and also agrees with the very excellent point that they have not yet seen 

enough data on long-term sequelae. She believes that there is more to come for understanding 

the morbidity associated with infection that may not always be reflected in the hospitalization or 

death rates. Including those 75 years of age and older in Phase 1b makes a lot of sense given 

the data presented on risk of hospitalizations and risk of death by age. In a sense, not only is 

this ensuring that they are maximizing the benefits for an incredibly high-risk population, but in 

her mind, that also potentially has a multiplier effect in that if they are at the tipping point in 

some healthcare systems with regard to capacity, those death rates get multiplied because of 

issues with health care capacity. They will have to pay close attention to where things are with 

capacity as the pandemic evolves and may need to be flexible going forward. With regard to 

essential workers, she highlighted the key points that are important from her perspective. She 

feels that it is incredibly important to focus in on the frontline health essential workers, those 

who need to get their jobs done and cannot do it without interacting with the public or with other

staff, and industries that may not have sufficient resources in place for mitigation. The risk of 

infection does remain high for frontline workers. She also thinks it is important to call out that 

where health and economic disparities are prominent, they also need to remain focused on 

addressing those disparities. She is hopeful that by focusing in on these frontline essential 

workers in particular, they can ensure that efficient and equitable allocation remains at the 

forefront in this category. As mentioned before, if sub-prioritization is necessary, frontline 

essential workers come to mind as where to emphasize implementation. She is hoping that by 

the time Phases 1c and 2 come along that there will be enough doses. If for some reason there 

are not enough doses at the time those Phases are ready to roll out, 1c may still be too large. 

Just as they had to reconsider Phase 1a and 1b in the context of the current pandemic, she 

thinks they have to be prepared to adapt in future phases because it is unknown where they will 

be in another month as those phases roll out. Therefore, they should continuously incorporate 

the data that they are seeing so that they can adapt the recommendations as needed.

Dr. Atmar added his congratulations to Dr. Dooling, Dr. Oliver, and the WG for providing a 

framework to address a very difficult question and problem. As he listened to the discussion, 

one of the things that he became concerned about was that based on the different groups that 

will be included in 1b, there will need to be different strategies to reach out to those groups to 

get them vaccinated. They also heard that the resources available to many of the public health 

entities across the nation are already quite stressed and the ability to reach out to a large 
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53

number of different target groups is potentially problematic. While he understood that the 

solutions need to be local, there also is the potential for local abuse that as schedules are not 

filled based on ACIP’s guidance, it is reasonable to move to other groups. He could see that in 

one community with a given vaccine supply, groups 1b and 1c could be moved through very 

quickly and the remaining individuals could begin being vaccinated, while another community 

might continue to vaccinate persons in group 1b. He asked whether the WG had considered this 

and if they had solutions for monitoring this.

Dr. Talbot emphasized that she is ever thankful for essential workers. She has a teenage boy 

who drinks a gallon of milk per day. Without front-facing critical workers who are still on farms, 

still processing the milk, and getting it into the grocery stores, it would be difficult in her home. It 

is not just the milk—it’s all of it. She feels very strongly that there is a balance of saving lives 

and keeping the infrastructure in place. As Dr. Duchin pointed out, it is easy to give vaccine in

clinics. It is not easy to give vaccines to the people who are on the frontlines for multiple 

reasons. One is that they have to take off time from work to do that. That is unpaid time that 

most of them cannot afford because they are not able to pay their bills. Second is if they do 

have fever post-vaccination, they have to take more time off work. She said she was really 

speaking to Senators and Congressmen and expressed hope that if they are not listening, their 

staffs were listening. It is critical to work with the White House to fund state health departments

to get vaccine out so that everyone can continue to get their milk and eggs and move that 

forward. She has been very impressed with many of the private groups that have come forward

and offered to help states. Where they are going to shine as Americans is through a lot of 

public-private partnerships to make this happen. Companies are going to have to open their 

doors to immunizers. It is going to take funding of states for them to be able to supply staff to do 

this kind of immunization. She implored Senators and Congressmen who were listening to 

please pay attention to this and please realize that funding is needed to move America past this 

outbreak. They love the vaccines that were funded, both of which are phenomenal, but funding 

is needed in the communities. 

Ms. Bahta echoed gratitude for the work of Drs. Oliver and Dooling in articulating the WG’s

sentiments. Looking at the various groups and examples, it was not clear to her where 

congregate settings fit in.

Dr. Dooling indicated that congregate settings fit in a number of ways. Corrections officers and 

workers were specifically called out as frontline essential workers. Other workers in congregate 

settings may be included as essential workers in Phase 1c. Dr. Oliver then presented that based 

on local decision-making, if the epidemiology and implementation factors both favor vaccinating 

workers and residents within a given congregate setting (be that prison, jail, or a homeless 

shelter) that this would be possible under the clinical considerations and general flexibility of 

recommendation.

Dr. Bernstein pointed out that the task of creating a plan is much more difficult than critiquing a 

plan, so he gave kudos and sincere gratitude for the wonderful work of Drs. Dooling and Oliver 

and the additional talented, bright, and insightful CDC folks and the entire COVID-19 Vaccine 

WG. He said he was struggling with the numbers. They heard from Dr. Messonnier earlier that

basically 100 million doses would be available in December, January, and February that in turn 

will accommodate 50 million individuals assuming they all accept it. The number of HCP, LTCFs 

residents, and frontline essential workers is 54 million. Then 3 million individuals are 75 years of 

age and older and then 65 to 74 years of age. He wondered how moving from one group to 

another was factored in or modeled as far as acceptance of the vaccine by these various 

groups.
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Dr. Cohn clarified that Dr. Messonnier’s comments were related to the number of individuals for 

whom a 2-dose series would be available by the end of each month. It did not mean that this 

would be the number of individuals who would be vaccinated in that month. By the end of 

December, there will be enough doses to vaccinate nearly 20 million people. By the end of 

January, there will be enough doses to vaccinate nearly 30 million additional people, and by the 

end of February, there will be enough doses to vaccinate 50 million additional people. That will 

help to better understand these numbers more, but uptake in these populations has not been 

modeled into the size of the groups. It is more related to the gating criteria and how quickly 

areas are able to move through these groups. Obviously, the hope is that uptake will be very 

high. However, it may not be very high immediately. For example, a huge number of individuals 

75 years of age and older might get vaccinated immediately, but then demand in that age group 

may decrease. Though people in that category may still come in to get vaccinated, a location 

may still have enough doses to move down to 65 years of age. They knew there would be 

variation and did not want to overwhelm demand based on the number of doses that will be 

available over January and February. They are hopeful that there will be enough doses to 

vaccinate through these groups sometime by the end of January or early February for the 

Phase 1b individuals.

Dr. Bernstein said he was just trying to do this as a balance sheet because he was separating it 

out be 75 plus versus the 65 to 74 year olds as their mortality is notably higher. The HCP, LTCF 

residents, essential workers, and those 65 and older essentially would be that 100 million 

individuals who could be covered in the next 3 months if there was 100% acceptance. He 

clarified that he was suggesting that ACIP consider adding persons aged 65 plus into Phase 1b.

Dr. Poehling express her thanks to Dr. Oliver, Dr. Dooling, and the entire WG for these very 

clear presentations and thinking about the path to vaccinating all who want to be vaccinated. 

Everyone hopes that the vaccine supply will increase faster than expected because these 

decisions are really wrenching right now. She agreed with the balance of morbidity, mortality,

and preservation of societal function. If she understood correctly, the 75 years and older group 

represents 8% of the population, 25% of the hospitalizations, and have the highest death rate. 

Frontline essential workers have the highest exposure and it is known that racial and ethnic 

disparities are attributable to increased exposure and prevalence of high-risk conditions. To get 

to what many have reiterated and what Dr. Cohn just said, to have 2 doses of vaccine for 50 

million people by the end of January and 100 million doses by the end of February, there is 

going to need to be an incredible amount of support to the public health infrastructure to be able 

to meet this opportunity. The faster they meet this opportunity, the healthier the US will be.

Dr. Gluckman (AHIP) added his gratitude to Dr. Dooling, Dr. Oliver, the WG, and the voting 

members of ACIP who have a difficult responsibility. Regarding the definition of essential 

workers not recommended in Phase 1b, the other essential workers, from an equity perspective,

in some of those professions many of people work completely in a remote setting. He wondered 

whether they should call out remote workers who do not meet other criteria for high-risk 

conditions to be considered in Phase 2 because he would have concern that people who are in 

low-income areas, minorities, and high-risk racial groups might be at higher risk than people 

who can protect themselves by the nature of their profession by being completely removed. He 

has been asked about the definition of “high-risk conditions” and asked if ACIP can be more 

explicit as they get closer to Phase 1c about medical risks for high-risk conditions. He was 

specifically asking if adults with developmental delay are considered to be high-risk. If they are 

living in a congregate setting, that is clearly specified. However, it was not clear to him whether 
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young people with developmental delay are considered to be in a high-risk condition simply

because of the nature of that condition.

Dr. Dooling said that how to handle workers who can do their job either entirely or mostly from 

home definitely was a topic the WG struggled with, and she welcomed input from other ACIP 

voting members and liaisons about clear direction on that point. Regarding high-risk conditions, 

they have relied on the ongoing review of the literature that CDC does to determine which 

conditions are associated with increased risk of COVID severity. At this time, there are 11 of 

these. CDC is constantly reviewing the literature to assess which conditions meet that bar of 

evidence.

Dr. Weiser (IHS) indicated that the Indian Health Service is the federal agency that is charged 

with upholding the federal trust responsibility to Tribal Nations across the country. Data from 14 

states were recently published in the MMWR on December 11, 2020 that demonstrated ageadjusted COVID-19-associated mortality among American Indians and Alaska Natives was 1.8 

times that of non-Hispanic whites. The risk of hospitalization and deaths associated with 

COVID-19 increased with age for both races and was higher for American Indians and Alaska 

Natives compared to whites. The relative disparity in mortality though was greatest for those 

who are aged 20 to 49 years. Among those in the 20 to 29 year age group, 30 to 39 year age 

group, and 40 to 49 year age group, the COVID-19 mortality rates among American Indians and

Alaska Natives were 10.5, 11.6, and 8.2 times respectively than rates among white persons. 

The burden of underlying diseases such as diabetes, obesity, heart disease, and chronic lung 

disease occurs in American Indians and Alaska Natives at much younger ages and is likely to 

be a major contributing factor to this disparity. Through Operation Warp Speed, the US 

government has considered IHS as a jurisdiction like states and has provided Tribes the option 

to receive COVID-19 vaccinations through either IHS or their states. Given the severity and 

rates of infection, hospitalization, and death experienced by American Indians and Alaska 

Natives and a unique government-to-government relationship between the federal government 

and Indian Tribes, consideration should be given to prioritize vaccines for American Indian and

Alaska Native people when supplies are scarce. Recognizing that the ACIP is reluctant to make 

a race-based preference, it is important to note that the Indian Tribes have a political, not a 

racial, status and there is an existing healthcare infrastructure specifically for American Indian 

and Alaska Native people that can be leveraged. With these considerations in mind, every effort 

must be made to ensure that not only the vaccines but the resources to distribute and 

administer vaccines for American Indians and Alaska Native people are provided to address 

these important disparities regardless of which jurisdiction, IHS or the state, is supplying 

vaccines for American Indian and Alaska Native people.

Dr. Cohn expressed appreciation for Dr. Weiser’s comment and the challenges of American 

Indian and Alaska Native populations. She clarified that allocations are different than how they 

are setting up prioritization. The prioritizations that ACIP will be voting on is meant to provide

high-level recommendations for where states and jurisdictions should allocate their doses of 

vaccine, knowing that there is flexibility with different circumstances in different communities. 

However, allocation decisions are being made by Operation Warp Speed. While CDC 

understands the concern, ACIP does not impact the allocation of doses to jurisdictions.

Dr. Howell (AIM) express gratitude on behalf of AIM for this additional guidance and 

consideration. She provided some context for what the 64 awardees are currently facing in 

terms of prioritizing vaccine at local and state levels. They are receiving multiple emails and 

phone calls from different employer groups and high-risk individuals wanting to be a priority for 

vaccination. It is refreshing to see the interest in vaccination, but it does place them in a very 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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difficult position. They surveyed their 64 members regarding Phases 1b and 1c and received 25 

responses. The survey was done prior to the information presented during this session, but 59%

of members preferred vaccinating 65 and older and those with underlying health conditions first,

41% said essential workers, and in the comments many did say they planned on doing a 

combination of the two. At the November ACIP meeting, results from a Harris Poll were 

presented showing public support for prioritizing healthcare workers, seniors, and 

immunocompromised individuals. She does think some very clear communication and talking 

points will be needed as to why frontline essential workers, who may be younger and healthier,

are being vaccinated over older individuals and those with multiple underlying health conditions. 

Of their membership, 68% reported being concerned about communications around that. The 

considerations presented during this session will be helpful in making decisions around 

prioritization of limited vaccine, and 76% of members said they wanted guidance regarding 

further prioritization of essential workers. More guidance regarding other congregate settings,

including homeless shelters, drug treatment centers, and corrections facilities would be 

appreciated. If staff choose not to be vaccinated, that leaves residents vulnerable to COVID-19,

many of whom have underlying health conditions. Logistically, it is much easier to vaccinate 

staff and residents at the same time. Many awardees have already started creating their own 

priorities. It is very likely that states may differ in their prioritization, which will make 

communicating with the public difficult and confusing. Based on another comment, a priority 

group is not something that is documented at the time of vaccination or generally documented in 

Immunization Information Systems (IIS). Therefore, it will not be possible to enforce prioritization 

and it will be difficult to determine uptake amongst these priority groups if they are not agebased. For planning purposes, she encouraged the committee to vote on both 1b and 1c so 

vaccination can be prioritized into the future, and she thanked them for the additional subprioritization and the considerations that were presented earlier.

Dr. Arthur (BIO) acknowledged that this is an amazingly complicated set of issues and 

expressed appreciation for the thoughtful approach of CDC and the WG. Regarding the 

manufacturing category in the frontline essential workers, BIO represents companies that are 

making key medicines as well as food and agriculture products. Obviously, many of their 

workers are part of the Homeland Security essential critical infrastructure workers. She asked 

that they clarify for states those workers within manufacturing who are key to infrastructure, 

making medicines, making food and agriculture products, and making PPE so that Governors 

and states can allocate doses to those populations as well who are manufacturing products that 

are needed for healthcare and other places. BIO also submitted a comment to the docket, but 

she wanted to make that case to the group as well.

Dr. DePalma (AAPA) thanked the committee members and everyone behind the scenes 

supporting those members for this important work and for the opportunity to be on these calls 

and speak. AAPA has heard from many Physician Assistant (PA) schools that thousands of PA

students are having their education delayed because health systems are afraid of exposing 

students to COVID and also of exposing patients to students who may be infected. There are 

thousands of PAs who, like physicians and Nurse Practitioners (NPs), will go on to work in 

hospitals, emergency departments (EDs), primary care, and other specialties who will be 

delayed in entering the health care workforce. Many of these students are young and healthy 

and would fall into Group 2 for vaccines. As important as it is to get the vaccines to older 

persons and frontline workers, she expressed her hope that ACIP would consider adding PA 

and other healthcare students to 1b or 1c so they can graduate and help with the current health 

crisis. A lot of health systems are not making vaccines available to students.
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Dr. Cohn clarified that in Phase 1a, the definition of HCP does include paid and unpaid HCP, 

which would include students. While there may be some confusion about that, those groups 

would be included in Phase 1a.

Dr. Hahn (CSTE) said that as a state health representative, what she fears the most is paralysis 

by analysis. That is, as they worry so much, and rightly so, about equity and fairness, they will 

be afraid to move forward or on to another group, even if vaccination is slowing down, because 

they are worried about creating a sense of inequity. She proposed that there is no way that 

everyone is going to be able to all stay lockstep. There need to be clear messages that there 

are going to be local decisions and local control. The worst thing that can happen is leaving

those vaccines in the freezer because of being afraid to move into the next group. They must 

have faith that local and state public health officials will do the right thing. She heard a comment 

about abuse of the vaccine. Clearly, there needs to be oversight as best as can be dome, but 

the locals need to be able to do what they think is right in their circumstances so that doses are 

not wasted. The number one goal is to get that vaccine out there and get folks vaccinated.

Dr. Kimberlin (AAP Redbook) requested that Slide 10 of Dr. Dooling’s presentation be put back 

up. While they had continued to talk over the last couple hours about frontline essential workers,

to his understanding, this was the only slide that actually lists them out. He wanted to confirm 

that when they talked about frontline essential workers, this referred to the bulleted group on the 

left-hand portion of this slide and that the same would be true all the way through the vote. Dr. 

Cohn confirmed this to be correct. Dr. Kimberlin emphasized the importance of this slide and 

requested that it be left up for as long as possible so that everyone would know what they were 

talking about. Obviously, he is representing the AAP and children are not part of this for reasons 

that are rather apparent. However, he did think that they would be supporting children by having 

educators in the frontline essential (e.g., teachers, daycare staff, support staff, and so forth) and 

he commended the inclusion of them as frontline essential workers.

Dr. Drees (SHEA) returned to the comment about remote workers because certainly within the 

healthcare workforce, there is a substantial proportion of people who are able to work remotely 

and are still essential. A hospital or clinic cannot function without its IT infrastructure working 

correctly or without the bills being submitted. They have observed that a lot of the COVIDpositive health care workforce is not necessarily from direct patient care. It is largely community 

exposure, which anyone is at risk of regardless of their actual job duties. There are also

healthcare worker-to-healthcare worker exposures from an asymptomatic or pre-symptomatic 

healthcare worker, which would put remote workers at somewhat less risk if they are working 

remotely. She expressed appreciation for the criteria for moving from Phase 1a to Phase 1b, but 

if the expectation is to have all of the remote health care workers vaccinated first, that would 

delay deployment to the 75 year old and older patient group, as well as the essential workers 

patient group. Some additional clarification around having a dual stream to capture remote 

workers but not hold off before starting on patients would perhaps be helpful.

Dr. Lee appreciated Dr. Kimberlin asking for the slide to put up as it was incredibly helpful. She 

also recognized that at a national level, ACIP will make some recommendations about

prioritization which they hope will translate into allocation, recognizing that it might not be 

perfectly aligned at a local and state level. But these recommendations are going to be 

imperfect. The group on the left of the slide provide a gestalt about the industries believed to be 

predominately frontline, but obviously as with health care workers and as Dr. Drees just 

mentioned, there are people in healthcare who are able to work remotely. The WG specifically 

tried to focus those doses on people who are actually on the frontlines. The same goes for each 

of these categories in that there are probably individuals in each of these groups who are 
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actually able to work remotely, whereas the majority will be on the frontline. She struggles 

somewhat with making these recommendations as firm and as clear as possible. Even though 

communication strategies should do that, it is really challenging to implement something like 

this. She wanted to make sure is that there is clarity around the recommendations and the 

intent. Thinking about Dr. Oliver’s slide around the ethics and questions that are being asked in 

the MMWR article, she strongly endorsed that each industry go back to those recommendations 

because those questions will get to the intent of what is meant by essential workers functionally. 

She 100% agreed that vaccines cannot be left sitting on the shelves. She recognized that there 

are huge implementation challenges with this and she does not think they should be policing 

who actually qualifies and who does not. The hope is that they could come together as 

communities, that each of these communities individually will be able to articulate who is truly 

frontline and who is not, and to partner with public health and healthcare delivery systems on

that. There is going to have to be some level of trust without being the police on this, but Dr. Lee 

also feels strongly that they need to be accountable. While vaccine cannot be left sitting on 

shelves and she still feels like efficiency is important, equity is still incredibly important. 

Therefore, they are going to have to find ways to ensure that we are actually measuring in some 

way the equity of distribution of these vaccines, even if they are not easy to do and without 

asking people to be the police. If they cannot do that, her worry is that, for example in Phase 1c,

it is going to be very easy for there to be insufficient doses. They cannot abandon equity just 

because it is hard to measure and hard to do.

Dr. Cohn indicated that CDC is working with local and state health departments as well as some 

of these industries to be able to measure and account for how many doses are being given to 

these different groups. There will be some way to measure the effectiveness of reaching

different groups who are prioritized for vaccination. She also mentioned to ACIP members that 

while these bullet points represent a high level list of employment groups that they recommend 

be included in the frontline essential workers, they are asking ACIP to vote on language that 

says, “frontline essential workers.” This is not black and white and it absolutely will vary by local 

context. Even employment groups in some localities may consider frontline workers that would

not make sense for other localities based on, for example, urban versus rural and different types 

of communities. 

Ms. Stinchfield (NAPNAP) said she could not thank the WG enough for their great work, 

especially since they had triple the meetings that ACIP did. She agreed with the 

recommendations, and especially has appreciated the paradigm of science, ethics, and practical 

implementation. She wanted to give voice, for a moment, from a person from hospitals and 

clinics who is responsible to implement and vaccinate Children’s Hospitals and Clinics of 

Minnesota, a large healthcare system where vaccine was due to arrive the next day. She 

emphasized that the image they see of the joyful shot in the arm really belies the work behind it. 

Hospitals and clinics are both elated and exhausted. The enormous heavy lift of operationalizing 

vaccinations in healthcare is not easy. Even though they do vaccinations, this is not easy. 

Extensive resources are needed for an overstressed, understaffed healthcare system that she 

would say is also on life support. Every hospital in the US has greatly appreciated the standard 

tools that CDC has provided (e.g., standing orders, screening tools, education). That is exactly 

what they needed so that every hospital is not trying to figure out the same process. This is 

saving resources and getting more around standard work. Significant help is needed for Phase 

1b folks who will really need significant help and will benefit from more tools, such as tools to 

help think through prioritization and even some mathematical considerations such as weighting 

at the local level, scheduling tools, and a state dashboard so that people know where they are in 

this process. Every state or every local level does not need to have to figure out a dashboard. 

Everyone should share resources and they should be pooled together in a centralized place 
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where they can learn from each other. For example, scheduling seems straightforward with 

Dose 1 followed by Dose 2 at 21 days later. However, implementing that with rolling clinics and 

different cohorts is a daunting task. Hospitals are short-staffed. People are out sick with COVID. 

They are out on quarantine. Many of them are the same nurses who are going to be 

vaccinating. Looking forward, logistical implementation tools and materials are needed in 

multiple languages to help those who are implementing category 1b and should be very 

important priorities.

Dr. Grogg (AOA) thanked everybody involved with the vaccines and recognized that this is a 

monumental task. He asked how HCP can get the vaccines for their offices and how individuals 

in different phases get notified from the state or know how to find vaccines.

Dr. Whitley-Williams (NMA) emphasized the importance supporting equitable access to 

particular communities of color as much as possible. While this is supported in words and she 

was very happy to hear Dr. Cohn say that there is going to be some monitoring throughout the

administration of vaccinations, it was not clear whether that would be done on a national basis

or would be something states would do. Assessing which groups are actually being vaccinated 

to determine whether those who are at highest risk are truly being reached is very important. 

She thanked the WG, CDC staff, and Drs. Romero, Bell, Dooling, and Oliver for a phenomenal 

amount of work. When she speaks to community persons, she tries to emphasize that some of 

the most caring people are working on this. She understands that the task is daunting, but 

moving forward it will be very helpful to be able to relay to the community that equity is being 

monitored in real-time as vaccine doses are administered.

Dr. Romero observed that there had been excellent comments on vaccine allocation, 

distribution, and administration. However, there also must be an educational component of this 

to the groups who are the frontline essential workers being prioritized in the Phases 1b and 1c 

categories. He is learning increasingly as he begins to offer education to the agricultural workers 

of the US that one size does not fit all. Methods must be developed that transmit to them their 

need for the vaccine and how to get the vaccine, reaching into those communities with culturally 

and linguistically appropriate educational measures.

Dr. Fryhofer (AMA) said that speaking as a practicing physician, she echoed the comments of 

Drs. Grogg and Goldman earlier pertaining to how HCP get vaccine for their offices. Physicians 

who are employed by the hospital are being taken care of, but she personally has received 

numerous emails from physicians wanting to know where to go. She received one email from a 

physician who is the Director of a Good Samaritan Clinic who was trying to figure out how to get 

vaccine for herself and her staff. This is a practice that takes care of people who do not have 

any other way of getting medical care—the most vulnerable. She has received emails from 

physicians who are doing locums. She was struck when Dr. Grogg asked that question that 

unlike the other questions that have been asked, there was silence and she realized that this is 

really not what ACIP can do. However, she thinks ACIP can raise awareness that this is a 

problem and that hospitals need to reach out past their walls to the community to make sure 

frontline HCP have access to vaccine so they can continue to take care of their patients. 

Dr. McKinney (APTR) asked Dr. Dooling or Dr. Oliver to comment on the risk for hospitalization 

and death among persons at 65 to 74 years of age who have one or more comorbid conditions 

versus those 75 and over all-comers since they are presented as being in different priority 

groups, 1b and 1c.
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Dr. Oliver said that she did not have those numbers readily available, but would see if they 

could get some information to share.

Dr. Shah (ASTHO) requested further information about the rationale for the inclusion of food 

service under the “other” category. By his reckoning, they are certainly essential but also are on 

the frontline. He understands that there will be nuances at the state level. He also was curious 

about how to let folks know when it is their time in line.

Dr. Zahn (NACCHO) appreciated that residents of homeless shelters and inmates/detainees of 

correctional facilities were included in the conversation of 1b and 1c. He recalled that there was 

some language about “depending on the local epidemiology and situation.” In terms of 

vaccinating persons experiencing homelessness or in shelter situations, it is important to 

understand their social, economic, and physical situation along with their often difficult 

relationship with and distrust of government. Anybody who was worked with this population

knows that it is a resource-intensive, long-term process to get them vaccinated. If he wanted to 

vaccinate that population locally, they would have to start doing it sooner rather than later.

There is not really an epidemiologic or local reason that would make him change that.

Dr. Messonnier thanked the ACIP members and liaisons for their very helpful comments. They 

will try in the clinical considerations document to be more specific about the thinking of the WG 

regarding why certain groups fell into certain categories and what it is meant to convey, with the 

hope that at least being able to articulate their rationale may help those on the frontlines who 

are the ones who actually will be faced with making a list and deciding who gets pushed to the

front and who gets pushed back. For example, regarding ethics and homeless shelters, 

language is included that reflects the WG’s consideration that there have clearly been several 

large outbreaks in those populations and that this may mean that some jurisdictions will need to 

prioritize those groups over others. Broadly, these comments are especially helpful because it 

points out to the CDC areas that need to be made clearer about the rationale. The CDC staff 

and the WG have tried to walk a careful line in providing an approach to this and the thinking 

behind it, but also have tried not to over-engineer it. As Dr. Hahn said, CDC recognizes that 

those on the frontlines within jurisdictions will have to turn this into implementable guidance. 

They tried to strike the correct balance, but will definitely be listening carefully for places where 

additional clarity or additional precision would be helpful to those who are going to be faced with 

making these tough choices.

Dr. Szilagyi acknowledged the tremendous amount of angst people were feeling about who 

exactly goes into Phases 1b versus 1c and said he understood, as he had a lot of angst about it 

himself. He pointed out that the hope is that all individuals who are in these groups will accept 

the vaccine. However, there are a lot of data from a number of surveys that suggest that while a 

lot of individuals want the vaccine, many want to wait and see. It is possible that Phase 1b will 

be passed through extremely quickly within weeks or a month even if everybody does it the way 

they really want to and even with the substantial amount of flexibility being provided to localities. 

One of his biggest concerns has to do with the need to provide a significant amount of effort,

resources, and outreach to enable vaccine confidence. This is especially true among 

communities of color and a lot of this is going to come at the local level.

Dr. Duchin (NACCHO) requested clarification about whether the nation’s public health workers 

who are involved in activities other than clinical (e.g., surveillance, disease and COVID outbreak 

investigation response, and planning for these vaccination programs) fall in the prioritization. It 

would be nice to have a list if possible.
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Dr. Dooling indicated that public health staff who have direct patient contact would be 

considered HCP under the current definition. Other public health workers are considered 

essential workers under the CISA definition and would fall under Phase 1c.

Dr. Poehling understood that there would be enough doses to vaccinate 30 million people in 

January and 50 million people in February. Recalling a comment from Dr. Bernstein earlier, she 

wondered whether 1b could include those 65 years of age and older and frontline essential 

workers.

Dr. Cohn said she thought one of the implementation considerations about sticking with the 75+ 

group as opposed to increasing is to allow for more targeted and focused vaccination, especially

given that all of these doses are not all available at the beginning of the month. It would dilute 

things to add 32 million 65 to 74 year olds. She called on other ACIP members who have been 

involved in the WG discussions. 

Dr. Bell said she thought the point being raised was very legitimate and reflected a lot of 

concern about balancing demand and supply and all of those considerations. Having the 

opportunity not to focus on an enormous group immediately has benefits. While the supply 

projections provided by HHS are greatly appreciated, they are only projections. Though she 

would love to believe that this is the way things are going to go, this is actually unknown. They 

certainly do not want supply to outstrip demand, but they also do not want to have to 

compromise. That is why the WG landed on this kind of balance for the moment. Being clear 

with suggestions about how to prioritize in Phase 1b, at least from the ACIP’s perspective, will 

be something they need to get ahead of relatively quickly. Her preference would be to wait and 

see for another period three weeks or so and if it appears that they are reaching Phase 1c, the 

ACIP could provide some additional guidance in terms of how to approach the large group of 

people in Phase 1c. On the other hand, if the ACIP feels strongly that they should go down in 

the age recommendations for the current recommendations, they certainly could take that up.

Dr. Romero said that as he thought about prioritization of the over 65 year old group, it was the 

number of individuals in that group and the supply that were most concerning to him. Coming to 

the proposed recommendation identifies the highest risk group within that age group and 

addresses what they believe to be vaccine availability at this time. As Dr. Bell pointed out, if

there is more vaccine than projected they can certainly open this up. However, including the 

entire group would prolong that phase significantly while waiting for more vaccine to become 

available. Given the two populations of essential workers and those individuals over 65 years of 

age, this is best way of melding the two groups together and giving an equitable and appropriate 

distribution of the vaccine to this group.

Dr. Lee agreed with Drs. Bell and Romero and felt comfortable that the WG had a chance to 

thoroughly deliberate and review the data at hand for the current Phase 1b recommendation.

She personally did not feel comfortable expanding on the fly because they need to look at all of 

the data in totality. If they feel the need to expand, she would advocate for another emergency 

meeting at another time.

Dr. Dooling emphasized that the clinical considerations could be very clear about gating criteria 

and make those specific to age.
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Dr. Sanchez said that while he was glad about the anticipation of being able to go through the 

phases quickly, he remained concerned about those 65 to 74 years of age and those with 

underlying medical conditions. Those groups can be sub-prioritized as well based on exposure 

risk. For instance, those who are retired should not fall into Phase 1b. However, some of the 

individuals in 1c who are older or have high-risk medical conditions and are still working, not 

working remotely, and are performing something important to society should be moved up 

versus those who are young and unlikely to have a more severe disease.

Dr. Talbot thought the WG referred to the long-term effects of COVID but were not very specific. 

She thought they probably should clarify what was meant by that for everyone listening. There 

are young adults who survive hospitalization but may not have a life as before because they 

have had strokes, heart failure, multiple amputations, et cetera. At this time, they do not have 

data on this. She thought they needed to be very cautious about saying that young adults would 

be fine. She spent the past week on back-up clinical call and read these charts and cried every 

day.

Dr. Szilagyi said he has agonized over the 65 and older age group as well. While he is not on 

the COVID Vaccine WG, he was concerned about making that decision at this time and 

suggested putting this into a sub-prioritization decision within 1c because it may end up being a 

combination of being between 65 and 75 and having one or more or multiple chronic conditions. 

Some individuals over 65 years of age are already in frontline workers or HCP, so they will 

already be covered. He suggested addressing this in a future meeting or try to get additional 

data to look at exactly who is high-risk. This would add another potential 20 million minus the 

overlap, so maybe 17 or 18 million of over 65 years old.

Dr. Romero added that the implementation of this, if sub-prioritized, puts a significant burden on 

health care and public health to identify individuals who have these comorbid conditions and 

may exacerbate the disparities because some individuals in this age group do not have access 

to medical care and cannot come up with a doctor’s note that will confirm that they have 

diabetes, hypertension, et cetera.

Dr. Hunter supported the current policy suggestion that was proposed for an ACIP vote in terms 

of leaving things to the way they are, with individuals 75 and older and the narrowed frontline 

essential workers. Going through the groups quickly is not necessarily a problem because he 

thinks it will address the concerns raised that they would get to younger folks faster.

Dr. Cohn thanked the ACIP members for the incredible thought that had been put into this 

challenging question. From an implementation perspective, the way that CDC has thought about

vaccinating persons with underlying illnesses is that one of the best ways to do so is to get 

vaccines into provider offices and pharmacies. In the near term, there will be the capacity to 

distribute vaccines more broadly to many more administration sites. The number of 

administration sites will likely increase with the Moderna vaccine being recommended and 

authorized. From an implementation perspective, it is easier identifying persons who have 

underlying health conditions when there is more vaccine to spread further. One thing they were 

hearing is some additional guidance around sub-prioritization within 1c may be helpful. For 

instance, prioritizing age or underlying medical conditions over some of the healthier nonfrontline essential workers may ensure that those groups are right behind the current groups in 

the Phase 1b group. They could recommend the groups in 1c during this vote and then could 

come back with some more specific clinical considerations or recommendations for the subprioritization of 1c.
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Dr. Bell indicated this had been a topic of discussion within the WG already and many of them 

are thinking about that as a next step.

Dr. Frey agreed with moving forward with the question and vote as it stood. She thinks they will 

move through these groups very quickly and they can only do so much at one time. She agreed 

with everything everyone was saying regarding their concerns, but they can only move so 

quickly and have a limited number of vaccines. More vaccines are forthcoming.

Dr. Atmar added his voice to the last few comments. When the WG went through the 

presentation initially, he wondered about the threshold at 75 years of age versus 65 years of 

age, but he was persuaded by the overall presentation, Dr. Bell’s comments about the 

uncertainty of the projected supply, and the likelihood that in a matter of as few as 2 to 3 weeks, 

that they could move from 1b to 1c so that the delay will not be that much greater before they 

are able to vaccinate persons over 65 years of age. Based on Dr. Bell’s comments, it sounded 

like the WG has already considered this. He requested that she and the other WG members 

take the concerns raised here back to the WG and if they feel there is a need for additional

guidance to bring it back to Dr. Cohn and the CDC administration for consideration of additional 

ACIP meetings. Dr. Cohn’s proposal of sub-prioritizing 1c was acceptable to him.

Dr. Bernstein expressed skepticism about the timeframe being weeks. While 2.9 million doses

of the Pfizer vaccine have been delivered, only about 300,000 doses have actually gone into 

arms. The reason he brought up those 65 to 74 years of age is because he feels that based on 

the numbers, the science, the risk of in-hospital deaths, the mortality rates, the incidence of 

COVID-19, and the hospitalizations with underlying medical conditions are awfully similar 

between the 65 to 74 and the 75 and above. It sounded from the discussion that this would 

evolve rather rapidly such that it would be offered to those 65 to 74 years of age rather quickly. 

While he understood that, he thought the science suggested moving them into one big group.

Dr. Shah (ASTHO) expressed appreciation for the flexibility afforded the states with respect to 

vaccination of individuals living in congregate settings. At the same time having clear guidance 

to ensure uniformity across the country also would help achieve the goals of equity to ensure 

that some states are not making decisions that prioritize or de-prioritize those individuals. He 

urged ACIP and CDC staff working on these issues to recognize in the flexibility to make 

recommendations as to where such individuals should be placed.

Dr. Lee said she felt very comfortable with 1b as it was and that moving forward with that 

particular decision needs to happen in order to help states and jurisdictions with planning. In 

terms of another nuance with respect to the challenges they heard about regarding Phase 1c, 

she fully endorsed the list of high-risk conditions based on the evidence to date that is coming 

through on the CDC website around high-risk conditions. The CDC also has been updating that 

in real time, which she really appreciates because every time she goes back to the website, she 

can usually find new information. While she thinks that will be a source of important guidance 

regarding prioritization for high-risk medical conditions, that focuses only on prevalent high-risk 

medical conditions. There are many low, rare, or less common medical conditions that put 

individuals at high-risk that do not come through in the data that they are seeing nationally. 

However, it was not clear where to put those individuals. For example, there are individuals with 

neuromuscular conditions whose respiratory condition is impaired who may not be on the list 

because they do not have sufficient numbers to demonstrate evidence of negative effect. 

Therefore, she thought they needed to think through 1c more carefully in terms of exactly what 

is included there.
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Dr. Cohn indicated that CDC would revise the clinical considerations document based on the 

input the voting and liaison members provided during this discussion, for which she expressed 

appreciation. 

Dr. Dooling re-read the proposed recommendation. Dr. Szilagyi made a motion, which was 

seconded by Dr. Frey, that ACIP approved the interim recommendation for allocation of initial 

supplies of COVID-19 vaccine for Phases 1b & 1c as written.

Dr. Lee said that while she felt very comfortable moving forward with the recommendation for 

Phase 1b, she felt that Phase 1c needed further discussion and she recommended splitting the 

vote between Phase 1b and 1c. In terms of the rationale for this proposed amendment to the 

motion, they heard concerns that there are perhaps additional considerations for prioritization 

that should be brought forward for further discussion if sufficient doses are not available for the 

entirety of Phase 1c. Because they did not review the list of high-risk medical conditions during 

the discussion, she did not feel comfortable without clarification on what that list entails or

moving forward with a vote on that.

Dr. Bell responded to Dr. Lee’s point by saying that there is nothing that precludes the ACIP 

from further clarification of Phase 1c even if they approved it the way it was currently proposed. 

She agreed that there was a definition for the underlying conditions in the form of the CDC list, 

and that the WG should discuss the list. Her concern for not having a vote for both 1b and 1c at 

this time was that would mean that all of the discussions about gating and having some 

flexibility of moving from one phase to the other would be dependent upon the WG and the 

ACIP reconvening in what could be a very short period of time to make an additional vote on 

Phase 1c. While she was fully committed to doing that if necessary, she did not see a downside 

to making some general statements about the Phase 1c available for states and localities now,

with the understanding that it will not be the final word of the ACIP on this process. She was 

concerned about having nothing on the table for the general direction of Phase 1c, which could 

be clarified by clinical considerations.

Dr. Messonnier reiterated and expanded on what Dr. Bell said. She was quite concerned at the 

idea of putting off a vote on getting beyond 1b. It is not clear how quickly they will make it 

through 1b to 1c and the jurisdictions are trying to plan out the next month or two of their work. 

Getting to some of these populations is quite difficult and requires a lot of on-ground logistics 

and planning. CDC is hoping that by getting through 1b and 1c, they can help them get started

on that process. They heard from several of the state and local health departments leads who 

had spoken that the folks on the ground are already basically working their way through these 

different phases. Therefore, she was concerned about putting off another vote, especially since 

that would mean putting it off until after the holidays. However, she offered her commitment that 

CDC would use the clinical consideration language as was done for HCP to provide the 

additional sub-prioritization as heard during the day from the ACIP members and liaison. They 

clearly heard the need to sub-prioritize in 1b based on age groups and they understand the 

need to be clearer about the high-risk medical conditions. All of those things will be rapidly 

incorporated into the clinical considerations. CDC’s desire is to at least get through both of 

these phases to avoid hampering CDC and the jurisdictions to do some more advanced 

planning.

Dr. Romero pointed out that there were now 2 motions on the table and either ACIP would have 

to vote on the first motion and then address Dr. Lee’s amended motion, or Dr. Lee could 

withdraw her motion.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

65

Dr. Sanchez said that as someone who raised the concern with Phase 1c in terms of the elderly 

and the high-risk medical conditions, his concern remained but he was very much satisfied with 

the comments from Drs. Messonnier and Cohn and saw the need to move forward with both 

Phases 1b and 1c recommendations. They have to provide guidance to the jurisdictions 

because this is rapidly evolving and they want to be able to ramp up all of the vaccination house 

programs. He was in agreement with moving forward with Phases 1b and 1c as presented, with 

the recognition that further sub-prioritization will be forthcoming very soon.

Dr. Poehling thanked Drs. Messonnier, Cohn, and Bell for their clarification and supported the 

recommendation as worded and recognized the importance of empowering public health in 

communities to prepare and the importance of educating. She requested that when working 

through the high-risk medical conditions that the WG consider whether the influenza high-risk 

medical conditions achieve the goal in trying to make it easier to implement.

Dr. Atmar called a point of order. There was a motion on the floor that was seconded and then

Dr. Lee put forth a motion to amend the original motion. Before discussing this further, he 

thought there should be a second to Dr. Lee’s motion or it should be withdrawn.

Dr. Lee withdrew the motion with a request that there needs to be more public discussion and 

transparency around the clinical considerations and the guidance. She otherwise was totally fine 

with the vote as originally recommended in order to support states and jurisdictions with 

planning. The Phase 1b and 1c discussion is on target. She has no concerns about 1b, but 

requested more open and transparent discussion about 1c, as she did not feel that they had 

fully and thoroughly addressed all of the considerations and rationale out into the open. Having 

the ability to do that would address her concerns.

Dr. Cohn made a process recommendation that they had a second of the original motion and 

Dr. Lee withdrew the proposal to amend the motion. Therefore, they had a motion on the table 

upon which to vote. She suggested that they take a break, move to public comment, and then 

revisit the question of the high-risk medical conditions. At that point, CDC could put up a couple 

of slides with some proposed critical considerations and would share the influenza high-risk 

conditions list, which would be consistent with additional high-risk conditions that are not on the 

COVID high-risk conditions, and get some feedback from the ACIP members before the vote. 

Conditions Associated with Severe COVID-19

Kathleen Dooling, MD MPH

Co-Lead ACIP COVID-19 Vaccine WG

Medical Officer, National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling presented additional information in response to some of the questions that were 

posed earlier by ACIP members and liaisons specifically to address the conditions associated 

with severe COVID or what are referred to as “high-risk medical conditions.” CDC has identified 

a list of conditions that make an individual at increased risk of severe COVID disease. This list is 

not exhaustive and only includes conditions with sufficient evidence to draw those conclusions. 

High-risk medical conditions may include other individuals based on consultation with an HCP

about personal risk factors. There is a constantly ongoing search of the literature that a team at 

CDC does. The conditions that have obtained the necessary evidence to be associated with 

severe disease are listed here and further information can be found on the CDC website:
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

66

 Obesity

 Severe Obesity 

 Type 2 Diabetes 

 Chronic Obstructive Pulmonary Disease (COPD) 

 Heart Condition 

 Chronic Kidney Disease (CKD)

 Cancer

 Immunocompromised State from Solid Organ Transplant 

 Sickle Cell Disease 

 Pregnancy

 Smoking (current or history)

Discussion Points

Dr. Poehling expressed appreciation to Dr. Dooling for pulling all of this information together so

that ACIP could review it. It highlights the fact that enough people with a certain disease will be 

needed to be able to rise to this list. The complications associated with Type 1 and Type 2 

diabetes are quite similar, with Type 1 being much less common. Therefore, she worries Type 1

is not showing up just because of the numbers. 

Dr. Dooling emphasized that this list is not exhaustive. It is absolutely correct that enough 

literature needs to come to the fore for it to get on the list. It is really in consultation with the 

HCP that personal risk factors are best assessed.

Dr. Frey pointed out that while COPD is listed, there are a lot of other chronic lung diseases that 

also are incapacitating.

Dr. Dooling said that those may come to the fore as time goes on and more is learned about this 

condition. The conditions that already are listed are certainly extremely prevalent in the 

population. An analysis with the BRFSS demonstrated that at least 56% of the population

among those 16 to 64 years of age has at least one of these conditions.

Dr. Lee appreciated that HCP could use their clinical judgment about the individual risk that any 

patient might have. This will be helpful because as was pointed out, there are many types of 

lung conditions that do not necessarily meet the definition of COPD but might be extremely 

relevant in terms of risk of severe disease to COVID-19 infection. She also highlighted that this 

list predominantly focuses on the adult population. Going forward, as vaccines become 

available for children, it might be helpful to further detail risk for pediatric populations because 

some of these conditions do translate over and others might be more objective in terms of 

whether that would be done through epidemiologic studies versus physician judgment.

Dr. Dooling indicated that a pediatric list is posted on the CDC website as well.

Dr. Bell thought it was useful to have this list for everyone to see and think through. She 

emphasized what Dr. Dooling said in terms of the list as currently configured including 

something more than half of the adult US population. In the context of limited supply, which is

where things are and will be when they get to Phase 1c, this is one of the challenges and 

something that the committee will need to deliberate on further. This list is not ordered in terms 

of strength of association. It is simply a reflection of conditions that have been shown to confer 

increased risk in epidemiologic studies. While she certainly thinks the list is useful and is

something for ACIP to work from, in the context of prioritization, which is presumably what they 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

67

will continue to need to be doing unfortunately for a little while, there are some further things 

that the committee will need to consider.

Dr. Atmar recalled that heart conditions, and more specifically hypertension, were on some of 

the early lists of more severe disease. He wondered whether in this list hypertension was 

contained within heart condition, which is a pretty generic category compared to COPD, which is 

a subset of lung condition.

Dr. Oliver indicated that the CDC website states, “heart conditions such as heart failure,

coronary artery disease, or cardiomyopathies.” It appears to be highlighting those and does not 

say “pulmonary hypertension.” There is a list of “are at increased risk” and “might be at 

increased risk” and there is a note that having other cardiovascular disease such as 

hypertension or stroke might increase one’s risk of severe disease from COVID-19.

Following the public comments, Dr. Romero took the Chair’s prerogative to make the following 

statement: I would like to make certain comments that I believe are within my purview as the 

Chair of the ACIP. It has been brought to my attention that through various outlets,

misinformation and statements made to impugn and undermine the work that the ACIP has 

carried out over these last 9 months, and more specifically over the last 2 months, has caused 

doubt among the American people as to our motives and decisions. It has been said that our 

recommendations are excluding specific racial groups. It is important that the public understand 

that throughout the long period of deliberation, the thoughtful discussion, and the careful 

evaluation of the data, the ACIP has struggled painfully to deal with distribution of a limited 

resource of vaccine. Our attempt has been always to achieve equitable, ethical, and fair 

distribution of that resource. We have never targeted a specific ethnic or racial group for receipt 

of the vaccine. Our decisions, recommendations better said, for the groups that are prioritized

take into account the burden of disease within those groups. Within those groups, 

White/Caucasian individuals predominate. The statements being made and carried throughout 

various outlets undermine the careful work that we have provided and undermine the trust of the 

American public in our committee. I want to emphasize again that we have never focused on 

any particular ethnic or racial group in coming to our recommendations. Thank you for allowing 

me to address that.

Dr. Cohn announced that the MMWR Moderna COVID vaccine was now live thanks to many 

people who got that out rapidly. The clinical considerations will be live soon as well and is one 

document that addresses both of the mRNA vaccine products. If the ACIP approved the 

recommendation that was proposed and seconded and the CDC Director approved the 

decision, an MMWR would be published in the coming week to describe these interim 

prioritization recommendations along with another clinical or implementation guidance 

document to accompany that MMWR.

Dr. Romero said he thought that for those in the ACIP, the recommendations reflect the very 

careful deliberation that they have had and the careful examination of data and serve to address 

the current lack of vaccine supply and those individuals who have the highest risk for disease. 

The recommendation will minimize the disease itself and improve equitable distribution across 

all segments of society. 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

68

Motion/Vote: Allocation of Initial Supplies of COVID-19 Vaccine: Phases 1b & 1c

Dr. Szilagyi made a motion, which was seconded by Dr. Frey, that ACIP approve the following 

interim recommendation for allocation of initial supplies of COVID-19 vaccine for Phases 1b & 

1c as written:

As an update to ACIP recommendations for vaccination in Phase 1a (health care personnel, 

and long-term care facility residents), if COVID-19 vaccine supply is limited, the following groups 

should be offered vaccination:

Phase 1b: persons aged ≥75 years and frontline essential workers

Phase 1c: persons aged 65–74 years, persons aged 16–64 years with high-risk medical 

conditions, and other essential workers

The motion carried with 13 affirmative votes, 1 negative vote, and 0 abstentions. The disposition 

of the vote was as follows:

13 Favored: Atmar, Ault, Bahta, Bell, Frey, Hunter, Lee, McNally, Poehling, Romero, 

Sanchez, Szilagyi, Talbot

 1 Opposed: Bernstein

 0 Abstained: N/A

Dr. Romero invited ACIP members to share their thoughts about why they voted as they did or 

to make additional comments.

Dr. Ault expressed appreciation for the amount of work that has gone into the discussions in the 

WG. While he was relatively silent in all of the forethought that went into this, he thought that the 

public comment section did raise some points and he wanted to make sure there are no gaps. 

Reflecting the comments received, he wondered whether there was a way to mention in the 

clinical guidance that there may be persons under 75 years of age who are not at home with 

caregivers who should be vaccinated.

Dr. Oliver indicated that they would be happy to address this in the clinical considerations.

Dr. Poehling pointed out that with the approval of two COVID vaccines and more studies 

currently ongoing, there is hope for ending this pandemic. While the hope is to provide vaccine 

to all Americans who want to get it, the ACIP was asked to provide recommendations during a 

time of limited vaccine availability to ensure safety and effectiveness; minimize transmission,

morbidity, mortality, and social disruption; and ensure equity in allocation distribution. This is 

why she voted for this prioritization schedule. She noted that persons 75 years and older 

represent 8% percent of the population, 25% of hospitalizations, and have a very high death 

rate. Frontline essential workers have high exposure. They include a disproportionate share of 

racial and ethnic persons who also have a disproportionate share of hospitalization. She also 

highlighted the need for federal support to move efficiently and effectively so that all Americans 

who want to be vaccinated can do so. Federal support is needed not only to develop the 

vaccine, but also to support the infrastructural needs of state and local public health and 

healthcare organizations to educate and administer vaccine to our communities.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

69

Ms. Bahta emphasized Dr. Romero’s comments prior to the vote and the need to ensure that as 

they consider these priority groups, they are examining how to reach those who do not access 

to healthcare readily or who may not have access to health care as much as possible in the 

guidance. It is critical to encourage state and local jurisdictions to plan out those groups that 

would not readily walk into a facility to get vaccinated.

Ms. McNally said that she voted affirmatively after hearing the data and the discussion. She 

made three points. First, she supports state flexibility to adapt the guidance as needed but

recognizes that there may be challenges with this flexibility and hopes states will have as much 

support as necessary to successfully get people vaccinated. Second, she appreciates the WG’s 

and CDC’s ongoing consideration of the priority of issue in persons aged 65 to 74 that was 

raised by Dr. Bernstein and discussed by the ACIP during the day, as well as the issues raised 

by Dr. Lee and the additional clinical considerations around 1c. Finally, as the consumer 

representative, she places value on public input and very much appreciates the CDC’s and 

WG’s attention to the feedback provided via focus groups, surveys, and the public comment in

the Federal Register.

Dr. Szilagyi said that he voted for this recommendation because in his opinion, it follows the 

evidence about the risks from coronavirus and the ethical principles that ACIP developed to 

maximize the benefits and minimize harms, promote justice, and mitigate health inequities.

ACIP is trying to “thread the needle” here. This was a difficult decision for him—really difficult,

because he truly wishes everyone could get the vaccine today and he knows high-risk 

individuals are not included in Phase 1b. However, over several months, as the vaccine supply 

ramps up, every American will have access to these safe and effective vaccines. There is now a 

need to devote sufficient resources to implement the vaccines, communicate the benefits and 

risks of the vaccines, and provide outreach to at-risk communities who are disproportionately 

affected by the pandemic. Finally, he thanked the scientists, CDC, ACIP, liaisons, and the public 

who have helped bring coronavirus vaccines to this nation. Before too long, vaccination and 

public health will triumph over this pandemic.

Dr. Sanchez reiterated his concern about, and hopefully the rapid introduction of, the vaccine

into Phase 1c as it becomes available because he feels strongly that the elderly and those with 

high-risk medical conditions should be prioritized over some essential workers who may be 

younger. While he is not doubting that some of them may have severe disease, he thinks they 

have to protect the elderly and high-risk medical condition individuals. He voted “yes” because 

he knows that there will have to be a prioritization schedule laid out to try to implement 

vaccination in that group. He also echoed the public comments about elderly homebound 

individuals who are not in LTCF and are cared for by family members, and that there needs to 

be outreach to those families as this is an important group who needs to be vaccinated as well.

Dr. Bernstein said that he is in full support of persons age 75 and older and frontline essential 

workers being in Phase 1b. However, he voted “no” because he feels that the science regarding 

COVID-19 morbidity and mortality presented earlier in the day by Dr. Dooling supported notable 

similarity between the 65 to 74 year old group and the 75 year old and older group. Therefore, 

inclusion of the 65 to 74 year old group in Phase 1b made more sense to him. He also believes 

that overall implementation of this unprecedented, complex, and national vaccination program 

will be simplified by doing so.
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Dr. Bell said she wished that they did not have to make allocation recommendations and that 

instead, there was enough vaccine to provide it to everybody in the country who wants it. 

However, in that they cannot, they are doing the best they can to make the best allocation 

recommendations under the circumstances. It has been said that emergencies bring out the 

best in people and it has been her experience that emergencies do bring out the best in people. 

This is an emergency in which everyone must do their part. They have to trust that everyone is 

doing their best and doing their part, and that they can all work together. She views the ACIP’s 

job and her job as doing their best to create the conditions for success and to facilitate a feeling 

of trust and of everyone doing their part. She expressed her hope that this would be an 

additional step in them doing that and trying to bring people together. Part of facilitating people 

to do their part is providing the conditions which make that possible. In that regard, the fact that 

the state and local health departments have not been funded for a vaccination program, 

especially in the context of the billions of dollars that funded the extremely successful program 

to develop vaccines, is really appalling. While she is just one person, she emphasized her hope 

that the government would address this discrepancy. Without this, she thinks it will be very 

difficult to be successful.

Dr. Talbot thanked Dr. Bell for highlighting how difficult this has been for all of them. For every 

group added, it means that a group must be subtracted. This has been incredibly humbling and 

heartbreaking. She looks forward to everyone having this vaccine and hopes to have a good 

party. She thanked the CDC members who have helped the WG through this process. It has not 

been easy, they have worked tireless hours, and she cannot say enough to thank them. She 

emphasized that it is incredibly important that the White House, Senators, and Congressman 

hear this—fund the vaccine infrastructure to get this vaccine out. This needs to be done rapidly 

and it needs to take precedence.

Dr. Lee stressed that the goal of ACIP is to ensure that they are providing access to safe and 

effective vaccines for the entire US population regardless of age, gender, race, ethnicity, or 

even personal or political beliefs about vaccines. She sees vaccines as a tool for creating hope,

unity, and a stronger community together. However, they have seen vaccines become used as 

a tool for misinformation, fears about allocation, and division within communities. In order to 

transparently explain her thinking about the vote, she wanted to emphasize that the ACIP is 

currently prioritizing vaccines to those at greatest risk for infection due to their occupation, such 

as frontline HCP and essential workers; and those at greatest risk for hospitalizations and 

death, such as LTCF residents, older adults, and those with high-risk medical conditions. These 

priorities reflect the racial, ethnic, and socioeconomic diversity of the US population, and also 

reflect that not all people in the US carry an equal share of the burden of COVID-19 infection 

and disease. Her hope is that these short-term recommendations will support efficiency and 

equity in every phase of vaccinations until the time when all individuals have access to safe and 

effective vaccines in the US and worldwide. Her hope is that despite the divisive voices they 

sometimes hear, all Americans can look to the ACIP; federal, state, and local public health 

leaders; and the provider communities to serve as trusted voices and partners in the effort to 

end the pandemic.

Dr. Atmar added his voice to how difficult a decision this was—probably the most difficult 

decision he has made during his term on the ACIP. Ultimately, he voted “yes” because he

thought that the data Drs. Dooling and Oliver presented and the considerations from the WG 

supported the prioritization of individuals into groups 1b and 1c. He feels comforted by the 

ethical framework that has been provided and the flexibility that local jurisdictions will have to 

make these prioritization recommendations fit into their local needs. They already have heard 

through public comments and through discussion that there can be exceptions that are not 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

71

specifically considered in the groups identified here. He also added his voice to the call for

funding of the public health infrastructure across the country. He is concerned that without this 

funding, the equitable distribution of vaccine to the groups identified as being at greatest risk 

could be jeopardized.

Dr. Frey said she was very much in favor of the language of the recommendation and the intent 

of the recommendation set by the WG to provide vaccines as quickly as possible to those at 

greatest risk of contracting disease and also those who will suffer the most severe outcomes. 

These were difficult decisions and there are no perfect recommendations. People will continue 

to become sick and die from this disease until there is adequate vaccine. She also pled for the 

leaders in government to move quickly on this and support this effort. The bottom line is that the 

decision-making will fall on the local government and those people tasked with making this 

happen. Her hope is to be able to provide them with significant and slightly more detailed 

guidance that they can use as the fluid parameters and conditions of deciding who needs to be 

vaccinated first.

Dr. Hunter said he strongly supports the recommendation and that it had been a privilege and 

an honor to work with the CDC staff and his fellow ACIP members over the past 4 years. 

Dr. Romero emphasized that the group has deliberated very carefully on this. This is without 

doubt the hardest vote that he has taken in his six and a half years on the committee. He is 

confident that they arrived at this by examining the data thoroughly. While the ultimate decisions

will be at a local level, ACIP is providing Governors and Health Officials with a framework which 

is supported by evidence, will address the limited supply of vaccine available at this time, and 

will maximize benefits and minimize harms.

Dr. Cohn thanked Dr. Romero and the ACIP members, pointing out that this would conclude the 

numerous meetings they have had over the last several months. The do anticipate having more

meetings. The next scheduled meeting will be at the end of February 2021, but there likely will 

be one additional meeting before February. Some of the topics raised during this meeting will 

need further discussion and hopefully there will be further information about additional vaccine 

products. Within the last week, Pfizer vaccines started shipping. Over the last week, 2,838,225 

have been distributed and 556,208 doses have been administered. This reflects an amazing 

amount of work that is happening at all of the administration sites and the amount of excitement 

and hope as many have seen from pictures that have been all over social media of HCP and 

soon LTCF residents as well. There will now be two products. While there was discussion 

throughout the day about limited supplies, she reminded everyone that it is an incredible feat to 

have vaccine so quickly, that there will be more doses, and that there is hope that there will 

continue to be increases in production as well as potentially new products early next year. 

These numbers will be updated on the ACIP site regularly. She thanked Dr. Romero for 

managing these meetings so seamlessly over the last couple of months; Drs. Dooling and Oliver 

and their entire team for the unquantifiable amount of work, thought, and effort that has gone 

into the last couple of meetings; and Stephanie Thomas, Chris Caraway, and Jessica MacNeil 

who always make sure ACIP meetings run smoothly even as they have transitioned to this 

virtual platform. She expressed her hope that she will get to see everyone soon because they 

will all be vaccinated and will be able to return to in-person ACIP meetings.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

72

Dr. Romero thanked Dr. Cohn and everyone for all of the work that they have done. He pointed 

out that the next day would be Winter Solstice, during which he asked everyone to take a few 

moments to reflect on this and take care of themselves. He said he would see them all in the 

near future, wished everyone Happy Holidays a prosperous New Year, and gaveled the meeting 

to a close.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

73

 

Upon reviewing the foregoing version of the December 19-20, 2020 ACIP meeting minutes, Dr. 

Jose Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.

Certification
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

74

Department of Health and Human Services 

Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

July 1, 2019 – December 31, 2020 

CHAIR 

ROMERO, José R., MD, FAAP 

Professor of Pediatrics 

Horace C. Cabe Endowed Chair in Infectious Diseases Director, 

Pediatric Infectious Diseases Section 

University of Arkansas for Medical Sciences and Arkansas Children's Hospital 

Director, Clinical Trials Research 

Arkansas Children's Hospital Research Institute 

Little Rock, AR 

Term: 10/30/2018-06/30/2021 

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS 

ATMAR, Robert L., MD 

John S. Dunn Clinical Research Professor in Infectious Diseases 

Departments of Medicine and Molecular Virology & Microbiology 

Baylor College of Medicine 

Chief, Infectious Diseases Service 

Ben Taub General Hospital, Harris Health System

Houston, TX 

Term: 7/1/2016 – 6/30/2020 

AULT, Kevin A., MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology 

University of Kansas Medical Center

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

ACIP Membership Roster
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

75

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023 

 

BELL, Beth P., MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

BERNSTEIN, Henry, DO, MHCM, FAAP 

Professor of Pediatrics 

Zucker School of Medicine at Hofstra/Northwell 

Cohen Children’s Medical Center 

New Hyde Park, NY 

Term: 11/27/2017-06/30/2021 

 

FREY, Sharon E., M.D. 

Professor and Associate Director of Clinical Research 

Clinical Director, Center for Vaccine Development 

Division of Infectious Diseases, Allergy and Immunology 

Saint Louis University Medical School 

Saint Louis, MO 

Term: 11/27/2017-06/30/2021 

 

HUNTER, Paul, MD 

Associate Professor of Family Medicine and Community Health 

University of Wisconsin School of Medicine and Public Health 

Associate Medical Director 

City of Milwaukee Health Department 

Milwaukee, WI 

Term: 7/1/2016 – 6/30/2020 

 

LEE, Grace M., MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 7/1/2016 – 6/30/2020 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

76

MCNALLY, Veronica V., JD 

President and CEO 

Franny Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

 

POEHLING, Katherine A., MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention Director, 

Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J., M.D.

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital 

Columbus, Ohio

Term: 7/1/2019 – 6/30/2023 

 

SZILAGYI, Peter, MD, MPH 

Professor of Pediatrics 

Executive Vice-Chair and Vice-Chair for Research 

Department of Pediatrics 

University of California, Los Angeles (UCLA) 

Los Angeles, California 

Term: 7/1/2016 – 6/30/2020 

 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS) 

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification 

Centers for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications Office of 

Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

Office of Infectious Disease and HIV/AIDS Policy (OIDP) 

KIM, David, MD CAPT, 

US Public Health Service Director Division of Vaccines 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, M.D. 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP) 

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, 

University of Michigan Medical School 

Medical Director, Dominos Farms Family Medicine Ann 

Arbor, MI 

 

American Academy of Pediatrics (AAP) 

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

 

American Academy of Pediatrics (AAP) 

Red Book Editor 

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine

Birmingham, AL 

 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C Senior 

Director, Clinical and Health Affairs 

American Academy of Physician Assistants

Alexandria, VA 

American College Health Association (ACHA) 

CHAI, Thevy S, MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill 

Chapel Hill, NC

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing 

Cornell Health 

Ithaca, NY 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 19-20, 2020

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American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH Lead 

Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast 

Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O., MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA 

American College of Physicians (ACP) 

GOLDMAN, Jason M. MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic 

University, Boca Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics 

Geriatrics Division Chief 

Duke University and Durham VA Medical Centers

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GLUCKMAN, Robert A., MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

American Medical Association (AMA) 

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine 

Emory University School of Medicine

Atlanta, GA 

 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN 
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Assistant Professor, Nursing Faculty 

Chatham University, School of Health Sciences

Pittsburgh, PA 

 

American Osteopathic Association (AOA) 

GROGG, Stanley E., DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

FOSTER, Stephan L., PharmD CAPT (Ret) 

U.S.P.H.S. 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND

 

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W. Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD

Director 

Maine Center for Disease Control and Prevention

Augusta, ME

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A., MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD State 

Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare

Boise, ID 

 
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Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

 

Canadian National Advisory Committee on Immunization (NACI) 

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

 

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J, MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine

Houston, TX 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD

Professor of Pediatrics

Boston University School of Medicine

Boston, MA

National Association of County and City Health Officials (NACCHO) 

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine, Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A., RN, MS, CPNP 

Director, Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota

St. Paul, MN 
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National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate) 

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD 

Professor and Chair 

University of Medicine and Dentistry of New Jersey 

Robert Wood Johnson Medical School 

New Brunswick, NJ 

 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

 

Pediatric Infectious Diseases Society (PIDS) (alternate) 

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B., MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center 

Oklahoma City, OK 
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Society for Healthcare Epidemiology of America (SHEA) 

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine Sidney Kimmel Medical College at Thomas Jefferson 

University 

Philadelphia, PA